Citation Nr: 1335564 Decision Date: 11/04/13 Archive Date: 11/13/13 DOCKET NO. 08-29 203 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Fort Harrison, Montana THE ISSUES 1. Entitlement to compensation under 38 U.S.C.A. § 1151 for hypertrophic cardiomyopathy, status post alcohol ablation, right bundle branch block with progressive complete heart block and implantable cardioverter-defibrillator (claimed as a heart disability). 2. Entitlement to service connection for a heart disability (hypertrophic cardiomyopathy, status post alcohol septal ablation, right bundle branch block with progressive complete heart block with implantable cardioverter-defibrillator). 3. Entitlement to a total disability rating for compensation purposes based on individual unemployability (TDIU). REPRESENTATION Veteran represented by: Robert M. Kampfer, Attorney at Law WITNESSES AT HEARING ON APPEAL The Veteran and C.F. ATTORNEY FOR THE BOARD M. Donohue, Counsel INTRODUCTION The Veteran had active service from August 1981 to May 1990. This matter comes before the Board of Veterans' Appeals (Board) on appeal from May 2007 and April 2009 rating decisions by the Department of Veterans Affairs (VA) Regional Office (RO) in Ft. Harrison, Montana. In July 2008, the Veteran presented testimony at a personal hearing conducted at the RO before a Hearing Officer. In July 2011, the Veteran testified before the undersigned Veterans Law Judge (VLJ). Transcripts of these hearings have been associated with the record. In March 2012 the Board remanded the Veteran's claim for additional evidentiary development. In April 2013, the Board requested a medical opinion from the Veterans Health Administration (VHA) in order to address the Veteran's claimed additional heart disability. See 38 U.S.C.A. § 7109 (West 2002); 38 C.F.R. § 20.901(d) (2013). The requested opinion was received by the Board in May 2013. On July 9, 2013, the Board wrote to the appellant, provided him a copy of the VHA opinion, and solicited additional evidence and/or argument. Cf. Thurber v. Brown, 5 Vet.App. 119 (1993). The issues of entitlement to service connection for a heart disability and TIDU are addressed in the REMAND portion of the decision below and are REMANDED to the Department of Veterans Affairs Regional Office. FINDINGS OF FACT 1. The May 2003 alcohol septal ablation procedure did not result in an additional disability. 2. The Veteran underwent surgery in June 2003 to insert an implantable cardioverter-defibrillator. 3. VA's deviation from the regulatory requirements for informed consent was a minor immaterial deviation under the circumstances of this case and a reasonable person in similar circumstances would have consented to receive an implantable cardioverter-defibrillator as the risk of forgoing the June 2003 surgery was sudden death. CONCLUSION OF LAW The requirements for compensation benefits pursuant to the provisions of 38 U.S.C.A. § 1151 for hypertrophic cardiomyopathy, status post alcohol ablation, right bundle branch block with progressive complete heart block and implantable cardioverter-defibrillator have not been met. 38 U.S.C.A. § 1151 (West 2002); 38 C.F.R. § 3.361 (2013). REASONS AND BASES FOR FINDINGS AND CONCLUSION After the evidence has been assembled, the Board is responsible for evaluating the entire record. 38 U.S.C.A. § 7104(a) (West 2002). When there is an approximate balance of evidence regarding the merits of an issue material to the determination of the matter, the benefit of the doubt in resolving each such issue shall be given to the claimant. See 38 U.S.C.A. § 5107 (West 2002); 38 C.F.R. § 3.102 (2013). Indeed, in Gilbert v. Derwinski, 1 Vet.App. 49, 53 (1990), the United States Court of Appeals for Veterans Claims (Court) stated that "a veteran need only demonstrate that there is an 'approximate balance of positive and negative evidence' in order to prevail." To deny a claim on its merits, the preponderance of the evidence must be against the claim. See Alemany v. Brown, 9 Vet.App. 518, 519 (1996), citing Gilbert, 1 Vet.App. at 54. Furthermore, the Board notes that it has reviewed all of the evidence in the claims file. Although the Board has an obligation to provide adequate reasons and bases supporting this decision, there is no requirement that the evidence submitted by the Veteran or obtained on his behalf be discussed in detail. Rather, the Board's analysis will focus specifically on what evidence is needed to substantiate the issue adjudicated herein and what the evidence in the claims file shows, or fails to show, with respect to this claim. See Gonzales v. West, 218 F.3d 1378, 1380-81 (Fed. Cir. 2000) and Timberlake v. Gober, 14 Vet.App. 122, 128-30 (2000). I. The Veterans Claims Assistance Act of 2000 (VCAA) The Veterans Claims Assistance Act of 2000 (VCAA), codified in pertinent part at 38 U.S.C.A. §§ 5103, 5103A (West 2002), and the pertinent implementing regulation, codified at 38 C.F.R. § 3.159 (2013), provide that VA will assist a claimant in obtaining evidence necessary to substantiate a claim but is not required to provide assistance to a claimant if there is no reasonable possibility that such assistance would aid in substantiating the claim. The law and regulations also require VA to notify the claimant and the claimant's representative, if any, of any information and any medical or lay evidence not previously provided to VA that is necessary to substantiate the claim. As part of the notice, VA is to specifically inform the claimant and the claimant's representative, if any, of which portion, if any, of the evidence is to be provided by the claimant and which part, if any, VA will attempt to obtain on behalf of the claimant. In March 2006, the Court issued its decision in the consolidated appeal of Dingess/Hartman v. Nicholson, 19 Vet.App. 473 (2006) and held that the notice requirements of 38 U.S.C. § 5103(a) and 38 C.F.R. § 3.159(b) apply to all five elements of a "service connection" claim. As previously defined by the courts, those five elements include: (1) veteran status; (2) existence of a disability; (3) a connection between the veteran's service and the disability; (4) degree of disability; and (5) effective date of the disability. Upon receipt of an application for "service connection," therefore, VA is required to review the information and the evidence presented with the claim and to provide the claimant with notice of what information and evidence not previously provided, if any, will assist in substantiating or is necessary to substantiate the elements of the claim as reasonably contemplated by the application. This includes notice that a disability rating and an effective date for the award of benefits will be assigned if service connection is awarded. The Board also notes that the Court has held that the plain language of 38 U.S.C.A. § 5103(a) requires that notice to a claimant pursuant to VCAA be provided "at the time" that, or "immediately after," VA receives a complete or substantially complete application for VA-administered benefits. Pelegrini v. Principi, 18 Vet.App. 112, 119 (2004). The timing requirement enunciated in Pelegrini applies equally to the initial-disability-rating and effective-date elements of a service-connection claim. Dingess, supra. In the present case, VA issued a VCAA notice letter to the Veteran in April 2008. This letter informed the Veteran of what evidence was required to substantiate his claim for compensation under 38 U.S.C.A. § 1151 and of his and VA's respective duties for obtaining evidence. The April 2008 letter also informed the Veteran as to the law pertaining to the assignment of a disability rating and effective date as the Court required in Dingess. In short, the record indicates that the Veteran received appropriate notice pursuant to the VCAA. The VCAA also provides that VA shall make reasonable efforts to assist a claimant in obtaining evidence necessary to substantiate a claim for VA benefits, unless no reasonable possibility exists that such assistance would aid in substantiating the claim. In this capacity, in March 2012, the Board remanded the case in order to gather additional VA treatment records and records from the Social Security Administration. The Veteran's claim was then to be readjudicated. The record reveals that the RO informed the Veteran of what records were of file and asked that he identify or submit any additional records he might have in an April 2012 letter. The Veteran's VA treatment records and records from the Social Security Administration were obtained and associated with his claims file. The claim was readjudicated via the December 2012 SSOC. Thus, the Board's remand instructions have been fully complied with. See Stegall v. West, 11 Vet.App. 268, 271 (1998) (where the remand orders of the Board are not complied with, the Board errs as a matter of law when it fails to ensure compliance); see also Dyment v. West, 13 Vet.App. 141, 146-47 (1999) (although under Stegall VA is required to comply with remand orders, substantial compliance, not absolute compliance, is required). In the present appeal, the Board finds that reasonable efforts have been made to assist the Veteran in obtaining evidence necessary to substantiate his claim, and that there is no reasonable possibility that further assistance would aid in substantiating it. In particular, the record contains the Veteran's service treatment records, VA treatment records, records from the Social Security Administration, VA examination reports, a VHA opinion, and the hearing transcripts. The Board has carefully reviewed the Veteran's statements and concludes that he has not identified further evidence not already of record. The Board has also reviewed the medical records for references to additional treatment reports not of record, but has found nothing to suggest that there is any outstanding evidence with respect to the Veteran's claim. As the Board will discuss in its analysis, the Veteran was provided with VA examinations in May 2009 and August 2010. A VHA opinion was also obtained in May 2013. The reports of these examinations and opinion reflect that the examiners reviewed the Veteran's past medical history, recorded his current complaints and rendered appropriate diagnoses and opinions consistent with the remainder of the evidence of record. Supporting rationale was also provided for the opinions proffered. See Barr v. Nicholson, 21 Vet.App. 303 (2007); Nieves-Rodriguez v. Peake, 22 Vet.App. 295 (2008). The Board therefore concludes that the examinations and VHA opinion are adequate for adjudication purposes. See 38 C.F.R. § 4.2 (2013). The Board additionally observes that all appropriate due process concerns have been satisfied. See 38 C.F.R. § 3.103 (2013). The Veteran has been accorded the opportunity to present evidence and argument in support of his claim. He exercised the option of a personal hearing and was afforded one in July 2008 and July 2011 as detailed in the Introduction. Based on the foregoing, the Board finds that all relevant facts have been properly and sufficiently developed in this appeal and that no further development is required to comply with the duty to assist the Veteran in developing the facts pertinent to his claim. Essentially, all available evidence that could substantiate the claim has been obtained. There is no indication in the file that there are additional relevant records that have not yet been obtained. II. Law and Regulations The law provides that compensation may be paid for a qualifying additional disability not the result of the Veteran's willful misconduct, caused by hospital care, medical or surgical treatment, or examination furnished the Veteran when the proximate cause of the disability was: (A) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing the hospital care, medical or surgical treatment, or examination; or (B) an event not recently foreseeable. 38 U.S.C.A. § 1151 (West 2002). VA regulations provide that benefits under 38 U.S.C.A. § 1151(a) for claims received by VA on or after October 1, 1997, as in this case, for additional disability due to hospital care, medical or surgical treatment, examination, require actual causation not the result of continuance or natural progress of a disease or injury for which the care, treatment, or examination was furnished, unless VA's failure to timely diagnose and properly treat the disease or injury proximately caused the continuance or natural progress. 38 C.F.R. § 3.361 (2013). If additional disability is shown to exist, the next consideration is whether the causation requirements for a valid claim have been met. In order to establish actual causation, the evidence must show that the medical or surgical treatment rendered resulted in the Veteran's additional disability. See 38 C.F.R. § 3.361(c)(1) (2013). In addition, the proximate cause of the disability claimed must be the event that directly caused it, as distinguished from a remote contributing cause. 38 C.F.R. § 3.361(d) (2013). It must be shown that the hospital care, medical or surgical treatment, or examination caused the Veteran's additional disability, and that (i) VA failed to exercise the degree of care that would be expected of a reasonable health care provider or that (ii) VA furnished the hospital care, medical or surgical treatment, or examination without the informed consent of the Veteran or the Veteran's representative. To establish the proximate cause of an additional disability or death, it must be shown that there was carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part in furnishing hospital care, medical or surgical treatment, or examination. Whether the proximate cause of a Veteran's additional disability or death was an event not recently foreseeable is in each claim to be determined based on what a reasonable health care provider would have foreseen. 38 C.F.R. § 3.361(d) (2013). III. Factual Background While being evaluated for "apparent bronchitis" in September 1998, the Veteran underwent an echocardiogram which revealed the presence of hypertrophic cardiomyopathy. Subsequent treatment records document that medication did not improve the Veteran's symptoms and an alcohol septal ablation was performed on May 30, 2003. Treatment records from the Veteran's surgery document that the alcohol septal ablation procedure was "successful" and his baseline resting gradient had been reduced from 85 mmHg to zero mmHg. These records also document that the Veteran developed a "Mobitz II heart block requiring transvenous pacing following the procedure" and that a temporary pacemaker was put in place. Following his surgery, VA treatment records note that when the Veteran's pacemaker was turned down, he was in sinus rhythm with first degree block. Based on the Veteran's history of syncope and his left ventricular diameter, it was determined that he was an increased risk of sudden death and was referred to the Salt Lake City VAMC for "urgent placement of [a] defibrillator (all defibrillators having pacing capability)." See a May 31, 2003 VA treatment record. When admitted at the Salt Lake City VAMC on June 1, 2003, it was noted that the Veteran's right bundle branch block and 1st degree atrioventricular block were new. He received an implantable cardioverter defibrillator (ICD) on June 3, 2003. On June 18, 2003, the Veteran was seen at the Fort Harrison VAMC for follow-up treatment where he reported that his defibrillator had "gone off about four times" in the past 10 days. The Veteran was hospitalized for chest pain on June 2, 2003 and an interrogation of his ICD revealed that there had been "no events." He was discharged the following day and arrangements were made for him to wear a Holter monitor. An analysis of the Veteran's Holter monitor revealed that he had experienced a 14 beat run of ventricular tachycardia and a 15 beat run of supraventricular tachycardia at a rate of 130-140 beats per minute. See, e.g., a July 17, 2003 VA treatment record. It was noted that the Veteran's ICD had not fired during these events because it was set to discharge at rates greater than 180 beats per minute. Id. The Veteran was admitted to the Fort Harrison VAMC on July 12, 2003 and was noted to have a 1st degree atrioventricular block. He was transferred to the Denver VAMC on July 17, 2003. When the Veteran was treated at the Denver VAMC, it was noted that he had been experiencing chest pain and there was a "question of whether his ICD has fired and the placement of leads." See the July 17, 2003 VA treatment record. These treatment records state that "it appears that the RV leads may be causing some diaphragmatic stimulation which would account for [the] Veteran having [the] sensation" of being shocked. He was scheduled to have his pacemaker lead adjusted; however, this does not appear to have occurred. A treatment record from August 21, 2003, documented the Veteran's complaint that his symptoms were "definitely worse" and included "increasing dyspepsia with minimal exertion, erratic heartbeat and fatigue." He complained of chest pain which radiates down his left arm, shortness of breath, and difficulty breathing that comes and goes throughout the day. On August 25, 2003, it was noted that the Veteran's complaints of fatigue and shortness of breath remained unchanged following the alcohol septal ablation procedure. The treating physician also explained to the Veteran that the "prickly" sensations in his chest and the visual disturbances that he experiences were there prior to his ablation and ICD and are not cardiac related. On October 24, 2003, the Veteran reported that he walked between two magnets at the Home Depot and became symptomatic with dizziness and tingling in his hand. He was directed to report to an Emergency Room. Private treatment records document that the Veteran was provided oxygen, placed on a cardiac monitor and an IV was started. His pacemaker was interrogated and found to be "functioning well." He was discharged home in stable condition. Due to a manufacturer recall of the generator for the Veteran's ICD, the Veteran underwent additional surgery in August 2005. During the surgery, the "visible portions of the leads were inspected and found to be in satisfactory condition." In January 2007, the Veteran was hospitalized after complaining that his defibrillator had been making a "siren" sound for the past three days which was followed by a "sense of warmth near his [ICD]." It was suspected that this "represents the [ICD] generating a charge but not delivering a shock, then warmth from dumping the charge." Treatment records from the Veteran's hospitalization document that he had a sinus rhythm with first degree atrioventricular block and bundle branch block. The Veteran underwent surgery for right ventricular lead revision. During surgery, it was determined that the ICD leads were normal but that the generator was providing false positive lead failures. The old generator was removed and a new ICD was implanted. When discharged on February 6, 2007, the Veteran's chest dressing was described as "clean[,] dry and intact." On March 26, 2007, the Veteran sought treatment for an infected ICD pocket. His infection was treated in March 2007 and a new ICD was implanted in April 2007. IV. Analysis The Veteran is seeking compensation under the provisions of 38 U.S.C.A. § 1151 for residuals of his May 2003 alcohol septal ablation procedure and the implantation of an ICD. See the July 2008 hearing transcript, page 15; see also the July 2011 hearing transcript, pages 3, 15-16, 21. As discussed in detail above, the Veteran received an ICD following his alcohol septal ablation procedure which was subsequently replaced on multiple occasions. He has not alleged, and the record does not reflect, that that the Veteran developed an additional disability due to the subsequent treatment/surgery for his ICD, or that his ICD was replaced due to carelessness, negligence, lack of proper skill, error in judgment or similar instances of fault on the part of VA. Based on the absence of any evidence or argument from the Veteran or his attorney pertaining to the subsequent ICD surgeries, and the absence of any evidence of an additional disability or fault on the part of VA, the Board need not address the treatment/surgery the Veteran received to replace his ICD. See Robinson v. Peake, 21 Vet.App. 545, 553 (2008) ("[T]he Board's obligation to analyze claims goes beyond the arguments explicitly made. However, it does not require the Board to assume the impossible task of inventing and rejecting every conceivable argument in order to produce a valid decision."), aff'd sub nom. Robinson v. Shinseki, 557 F.3d 1355 (Fed. Cir. 2009). Instead, the Veteran has argued that he was not informed of the risks of the alcohol septal ablation procedure, that he did not sign a consent form prior to this surgery, and that he has an additional disability as a result of VA "inadvertently" burning his septum. See the July 2008 and July 2011 hearing transcripts. The Veteran has also argued that he was not informed of the potential need for a permanent pacemaker or ICD and that he did not consent to undergo surgery to insert an ICD following his alcohol septal ablation procedure. As discussed in detail below, the Veteran's alcohol septal ablation procedure and the implantation of an ICD were mutually exclusive events. The Board will address each surgery in turn. A. The Alcohol Septal Ablation Procedure As an initial matter, the Board notes that alcohol ablation is the "destruction of tissue by injection of small amounts of alcohol or phenol; used in the treatment of tachyarrhythmias and hypertropic cardiomyopathy." See Dorland's Illustrated Medical Dictionary, 4 (30th Ed. 2003) (Cited for definitional purposes only.) The Veteran has also submitted a medical treatise article which explains that during the procedure, dehydrated ethanol is injected to the septum "causing a targeted myocardial infraction." Michael Fifer, M.D., Alcohol septal ablation for hypertrophic obstructive cardiomyopathy, Cardiology Rounds, January 2003. The law and regulations pertaining to claims under section 1151 have been set forth above. In Viegas v. Shinseki, 705 F.3d 1374 (Fed.Cir. 2012) the United States Court of Appeals for the Federal Circuit (Federal Circuit) observed that "section 1151 delineates three prerequisites for obtaining compensation." First, a claimant must "incur a qualifying additional disability which is not the result of his own willful misconduct." Second, the additional disability "must have been caused by hospital care, medical or surgical treatment," or from an examination furnished to the Veteran by VA or in a VA facility. "Finally, the proximate cause of the veteran's disability must be carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA or an event not reasonably foreseeable." Viegas at 1377 (Internal quotations omitted). In order to determine whether an additional disability is present, the Veteran's condition immediately prior to the disease or injury on which the claim for compensation is based is compared with the subsequent physical condition resulting from the disease or injury. 38 C.F.R. § 3.358. As discussed in the factual background section above, records surrounding the Veteran's alcohol septal ablation indicate that the procedure was successful and his baseline resting gradient had been reduced from 85 mmHg to zero mmHg. However, these records also indicate that the Veteran developed a Mobitz II heart block, first degree block, right bundle branch block and continued to experience fatigue and shortness of breath. In order to determine whether the May 2003 alcohol septal ablation procedure resulted in an additional disability, the Board obtained the opinion of a VHA physician in May 2013. After reviewing the claims file, the examiner noted that the commonly accepted definition of a disability is "a physical or mental impairment that substantially limits one or more of a person's major life activities." Using this standard, the examiner noted that the Veteran's "Mobitz II heart block, first degree block, and right bundle branch block do not cause a substantial limitation in the Veteran's major life activities and therefore do not lead to any additional disability." The Board has considered the Veteran's argument that VA accidentally burnt his septum which resulted in an additional disability. However, in the several hundred pages of treatment records contained in the Veteran's claims file, there is not one single mention of the ablation procedure resulting in damage to the Veteran's septum other than what was anticipated. Additionally, while the Veteran's father issued a statement July 2009 wherein he recalled being told that the surgery "didn't turn out" as planned, this is directly contradicted by the contemporaneous surgery report, the VA examination reports, and the VHA opinion. While cognizant that the Veteran continued to experience fatigue, shortness of breath, chest pain, and visual disturbances following his surgery, the record indicates that these symptoms existed prior to his surgery. See an August 25, 2003 VA treatment record; see also a May 29, 2003 VA treatment record. Further, while an August 21, 2003 VA treatment record documents the Veteran's complaints that he was "definitely worse" following his surgery, a separate treatment record from August 21, 2003, notes that all objective tests results indicate that there has been an improvement in the Veteran's heart disability and that his subjective complaints are identical to those made prior to his surgery. The Board has considered the Veteran's statements that he had an additional disability following his surgery as well as the statement from the Veteran's father that the surgery did not go as planned. Indeed, lay witnesses are competent to report on information of which they have personal knowledge. See Layno v. Brown, 6 Vet.App. 465, 470 (1994) Lay witnesses are also competent to opine as to some matters of diagnosis and etiology, and the Board must determine on a case by case basis whether a veteran's particular disability is the type of disability for which lay evidence is competent. See Davidson v. Shinseki, 581 F.3d 1313 (Fed. Cir. 2009); Kahana v. Shinseki, 24 Vet.App. 428, 435 (2011). In this case, however, the Veteran's testimony that the alcohol ablation procedure destroyed excess tissue or that he has an additional heart disability as a result of his surgery is testimony as to an internal medical process which extends beyond an immediately observable cause-and-effect relationship. His allegations are of the type that the courts have found to be beyond the competence of lay witnesses. See, e.g., Jandreau v. Nicholson, 492 F.3d 1372 (Fed. Cir. 2007). Accordingly, while the Board has considered the Veteran's statements that he has an additional disability as a result of the alcohol ablation procedure, as a layperson not shown to possess appropriate medical training and expertise, the Veteran is not competent to render such a diagnosis or opinion. Such a determination requires medical expertise. See Jandreau, supra. Thus, the Veteran's statements are not competent medical opinions. As a result, the record does not contain any competent evidence of an additional disability. With respect to the statements from the Veteran's father, as a layman, he is competent to report what he has been told. Jandreau, supra. However, the Board places greater weight of probative value on the surgery report, numerous VA treatment records, VA examination reports, and VHA opinion which indicate that the Veteran's alcohol septal ablation procedure went according to plan. These records cite to objective test results which show an improvement in the Veteran's baseline resting gradient. These records also note that the Veteran's subjective complaints are identical to the symptoms he experienced prior to surgery. Upon review, the only evidence of record which indicates that the procedure did not go according to plan comes from the unsupported statements of the Veteran and his father. As the Veteran and his father have not provided any rationale for these allegations, the Board affords them little probative value. In sum, the lay statement from the Veteran's father is inconsistent with the contemporaneous record and is not credible. As alluded to above, the Veteran has noted that the information on the consent form for the alcohol septal ablation procedure notes that a temporary pacemaker may be required. The Veteran has argued that he received an ICD following this procedure due to an error that was committed during surgery. Contrary to the Veteran's statements, the record indicates that the Veteran's ICD is not related to his septal ablation procedure. In fact, the May 2013 VHA examiner reported that implantation of an ICD was indicated "irrespective of the outcome of the alcohol septal ablation." Further, treatment records which predate the Veteran's ablation procedure note that he was a high risk patient would need an evaluation to determine whether an ICD was required. The Board observes that the March 2009 VA examiner stated that "a well documented side effect of [the ablation procedure] is the disruption in regular cardiac rhythm," and during his surgery, "a pacemaker was placed in order to maintain a regular heart beat." However, in August 2010, the same examiner noted that the Veteran received an ICD to prevent sudden death due to cardiac arrhythmias, not as a pacemaker, but that ICDs "also happen to be pacemaker devices." It was further noted that the Veteran would "need to have the [ICD] placed, regardless if he underwent the alcohol ablation therapy or not" due to his idiopathic hypertrophic subaortic stenosis, increased septal muscle muss and multiple syncopal episodes. Accordingly, the record indicates that the Veteran did not require an ICD due to an error with his alcohol septal ablation procedure, but that this device was required irrespective of his alcohol septal ablation procedure. While the Board has considered the Veteran's testimony to the contrary, he has provided no rationale for his statements and the treatment records prior to his surgery and the VA and VHA examiners have indicated otherwise. Even if the Board were to assume some level of competence on the part of the Veteran, his opinion lacks reasoning and is far less probative that the actual medical evidence in this case. As the weight of the evidence of record is against a finding of additional disability due to the Veteran's May 2003 alcohol septal ablation procedure, the criteria for compensation under 38 U.S.C. § 1151 have not been met. The Board further notes that in the absence of additional disability, no inquiry need be made as to the second or third elements set forth in Viegas. Nevertheless, while the Veteran's claim is being denied based on the lack of an additional disability, the Board will briefly address his claim that he was not informed of the risks of the surgery and did not sign a consent form. In this capacity, the Board also notes that the Veteran's father issued a statement in June 2009 which alleges that VA personnel did not seek to obtain the Veteran's consent for the alcohol ablation procedure until after the surgery was performed. Upon review, the record contains a consent form for the alcohol septal ablation procedure which bears the Veteran's signature and is dated prior to his surgery. This document also lists the potential risks involved with the procedure. While the record reflects that the Veteran was asked to sign a consent form after his surgery, this document addressed his participation in a research study and is unrelated with his consent to undergo the alcohol ablation procedure. While the Veteran has testified that his signature was forged, he has provided no evidence in support of this assertion and the signature on this document is substantially similar to other signatures contained in the claims file. As a result, the Board places little weight of probative value on the statements of the Veteran and his father. In any event, as discussed above, the weight of the evidence of record is against a finding of additional disability due to the alcohol septal ablation procedure performed on May 30, 2003, and the criteria for compensation under 38 U.S.C. § 1151 have not been met on this basis alone. There is no reasonable doubt to be resolved in this case. See 38 U.S.C.A. § 5107(b) (West 2002); 38 C.F.R. § 3.102 (2013); Gilbert v. Derwinski, 1 Vet. App. 49 (1990). B. Implementation of an ICD The Veteran has argued that he was not informed of the potential need for an ICD and that he did not consent to undergo this procedure. See the July 2011 hearing transcript, page 3. As discussed above, in order to obtain compensation under 38 U.S.C.A. § 1151, the record must demonstrate: (1) a qualifying additional disability; (2) that the additional disability was caused by VA treatment or in a VA facility, and; (3) the proximate cause of the veteran's disability was the result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA or an event not reasonably foreseeable. Viegas at 1377. With respect to the matter of an additional disability, in the May 2013 VHA opinion, the examiner noted that the Veteran could no longer be employed as an arc welder as a result of the implantation of the ICD. While the record includes a letter from an ICD manufacturer which indicates that it "is usually possible for welders who have had an ICD implanted to return to work" the Board places greater weight of probative value on the VHA examiner than a generic letter issued by the ICD manufacturer. A current disability has therefore been demonstrated. In addition, there is no question that the Veteran has satisfied section 1151's first causation element (the second Viegas element) since the additional disability was caused by VA treatment. Specifically, the Veteran's ICD was implanted during surgery by VA staff at a VA hospital. As a result, the remaining issue is whether the proximate cause of the Veteran's additional disability was the result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA, or an event not reasonably foreseeable. Here, the Veteran has not argued that VA failed to exercise a degree of care that would be expected of a reasonable health care provider. He has also not alleged that the implementation of the ICD was not a reasonably foreseeable consequence of his surgery. (Indeed, the Veteran underwent surgery in order to have an ICD implanted.) Instead, the Veteran has argued that he was not informed of the risks of the procedure and did not provide consent for the surgery. Upon review, the record does not contain a consent form which lists the nature of the procedure, the expected benefits, reasonably foreseeable risks, reasonable alternatives, or anticipated results if nothing is done. The Veterans Court has addressed a situation where there was a signed consent form but the form did not provide specific information as to the risks of the surgical procedure, including the specific complication suffered by the patient. See McNair v. Shinseki, 25 Vet.App. 98 (2011). In that case, a veteran suffered neuralgia as a result of breast reduction surgery and the written consent form of record did not indicate that neuralgia could result from this procedure. Id. at 101. In McNair, the Veterans Court held that the failure to advise a patient of a foreseeable risk can be considered minor, immaterial deviation under Section 17.32 if a reasonable person in similar circumstances would have proceeded with the medical treatment even if informed of the foreseeable risk. Id. at 107. Ultimately, the Veterans Court remanded that case and in doing so provided guidance, stating that "the Board did not discuss, and the record does not reflect, the consequence of proceeding with the surgery versus foregoing surgery, which are key factors upon which one might evaluate whether a reasonable person would have proceeded with the surgery." Id. at 107-08. The Board is aware that the facts of this case differ from those in McNair in that in McNair there was a signed consent form and here there is no signed consent form prior to the Veteran's June 2003 surgery. However, the Board finds that this difference does not preclude analysis under McNair. However, the difference between a signed consent form that does not list the specific risk experienced by the patient, as was the case in McNair, is not materially different from the lack of a signed consent form. In neither case is there a signed consent form that shows that the patient was informed of the specific event that occurred. The analysis of the facts of this case under the guidance provided in McNair is appropriate. Although there is no signed consent form prior to the Veteran's June 2003 surgery, the Veteran's treatment records indicate that informed consent was obtained. Specifically, a June 2, 2003 arrhythmia inpatient note states that the procedure was "discussed at length" with the Veteran and risks, including, but not limited to death, myocardial infarction, cerebrovascular accident, major bleeding, need for emergent surgery or transfusion, pneumothorax, infection, lead dislodgement, need for repeat procedure were also discussed. It was noted that the Veteran "expressed understanding and consents to proceed." More importantly, the record repeatedly indicates that the Veteran needed an ICD because he was at risk of "sudden death." See, e.g., a May 31, 2003 VA treatment record. During the August 2010 VA examination, it was noted that the Veteran had an enlarged septum which "posed a very high risk of developing sudden cardiac death due to cardiac arrhythmias. The chance of survival from these types of arrhythmias is greatly reduced if a defibrillator is not immediately available at the time of the event." The examiner noted that an ICD "is the best course of action to prevent morbidity and especially mortality." As the record reflects that an ICD was the "best course of action" to prevent the Veteran's death, that the likelihood of his surviving cardiac arrhythmias without such a device was "greatly reduced," and that the device was being implanted to prevent his "sudden cardiac death," the Board finds that a reasonable person in the Veteran's position would have elected to undergo have an ICD implanted in order to preserve their own life. Accordingly, the Board finds that the lack of a signed informed consent form for the June 2003 treatment was a minor immaterial deviation from the requirements of 38 C.F.R. § 17.32. In summary, the preponderance of evidence shows that the proximate cause element of the Veteran's claim under 38 U.S.C.A. § 1151 is not met in this case. Therefore his appeal as to compensation for additional disability resulting from the June 2003 surgery must be denied. There is no reasonable doubt to be resolved in this case. See 38 U.S.C.A. § 5107(b) (West 2002); 38 C.F.R. § 3.102 (2013); Gilbert v. Derwinski, 1 Vet. App. 49 (1990). ORDER Entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 for additional disability claimed as a result of Department of Veterans Affairs medical treatment, including alcohol septal ablation and ICD placement, is denied. REMAND After having carefully considered the matter, and for reasons expressed immediately below, the Board believes that the remaining issues must be remanded to insure full compliance with the statutory duty to assist. The Veteran has argued that he developed heart disability as a result of his in-service exposure to coccidiomycosis. See, e.g., the June 2011 hearing transcript. The Board notes that coccidiomycosis is an endemic fungal disease originating in the soil of certain regions of the country which affects the lungs and is "occasionally disseminated to other parts of the body" which results in individuals becoming "very ill and [requiring] strong IV medication." See the March 2007 VA examination report. The Veteran was afforded a VA examination in March 2007 in order to determine the etiology of his heart disability. After reviewing the evidence of record, the VA examiner stated that the Veteran's "hypertrophic cardiomyopathy is a condition involving abnormal heart muscle fiber, which is either inherited autosomal dominant or due to a chromosomal gene mutation." In March 2009, after reviewing the claims file, a separate VA examiner stated that obstructive hypertrophic cardiomyopathy "is most often described as a congenital condition." The Board notes that congenital or developmental defects are not diseases or injuries within the meaning of the applicable legislation. 38 C.F.R. §§ 3.303(c), 4.9 (2013). Such conditions are part of a life-long defect and are normally static conditions which are incapable of improvement or deterioration. See VAOGCPREC 67-90 (1990). VA regulations specifically prohibit service connection for a congenital or developmental defect, unless such defect was subjected to a superimposed disease or injury which created additional disability. See VAOPGCPREC 82-90 (July 18, 1990) (cited at 55 Fed. Reg. 45,711) (Oct. 30, 1990) (service connection may not be granted for defects of congenital, developmental or familial origin, unless the defect was subject to a superimposed disease or injury). See also Carpenter v. Brown, 8 Vet. App. 240, 245 (1995); Monroe v. Brown, 4 Vet. App. 513, 514-15 (1993). In any event, service connection may be granted for diseases (but not defects) of congenital, developmental or familial origin if the condition was incurred in or aggravated during service. While a defect is a structural or inherent abnormality or condition that is more or less stationary in nature, a disease is defined as any deviation from or interruption of the normal structure or function of any part, organ, or system of the body that is manifested by a characteristic set of symptoms and signs and whose etiology, pathology, and prognosis may be known or unknown. See VAOPGCPREC 82-90, 56 Fed. Reg. 45711 (1990). Currently, the record is unclear as to whether the Veteran's obstructive hypertrophic cardiomyopathy is a congenital defect or a congenital disease that was incurred in or aggravated in service. An additional opinion is therefore required. Therefore, in order to give the Veteran every consideration with respect to the present appeal and to ensure due process, it is the Board's opinion that further development of the case is necessary. Finally, the Board notes that the TDIU claim is inextricably intertwined with the Veteran's service connection claim, as the resolution of that claim might have bearing upon the claim for TDIU. The appropriate remedy where a pending claim is inextricably intertwined with a claim currently on appeal is to remand the claim on appeal pending the adjudication of the inextricably intertwined claim. Accordingly, the case is REMANDED for the following action: 1. The RO should obtain a medical opinion to determine the etiology of any and all heart disabilities that may be present. The examiner is requested to review all pertinent records associated with the claims file, including the Veteran's service treatment records, post-service medical records, and lay statements. The examiner should identify all current heart disabilities. If the Veteran has a heart disability other than obstructive hypertrophic cardiomyopathy, the examiner should state whether it is at least as likely as not that the disorder manifested in service or is otherwise related to his military service, including his symptomatology therein. With regard to his obstructive hypertrophic cardiomyopathy, the examiner should address the following: A. Based on the record, did the Veteran have heart disease, injury or disease during service? B. Is the Veteran's obstructive hypertrophic cardiomyopathy a congenital "disease" or a congenital "defect"? To assist the examiner, the Board notes that, for VA adjudication purposes, "disease" generally refers to a condition considered capable of improving or deteriorating, whereas "defect" generally refers to a condition not considered capable of improving or deteriorating. (As an example, VA considers sickle cell anemia as congenital "disease" for VA purposes whereas refractive error is considered a congenital "defect"). C. If the examiner concludes the Veteran's obstructive hypertrophic cardiomyopathy is a congenital disease, the examiner should then render an opinion as to whether the disease preexisted the Veteran's military service. If so, the examiner should state whether it underwent a permanent increase in severity during his active service and whether any permanent increase was due to the natural progress of the condition. D. If obstructive hypertrophic cardiomyopathy is not congenital and/or did not preexist service, the examiner should state whether it is at least as likely as not that the disorder manifested in service or is otherwise related to his military service, including his symptomatology therein. A clear rationale for all opinions would be helpful and a discussion of the facts and medical principles involved would be of considerable assistance to the Board. Because it is important "that each disability be viewed in relation to its history [,]" 38 C.F.R. § 4.1, copies of all pertinent records in the appellant's claims file, or in the alternative, the claims file, must be made available to the examiner for review. 2. After completing all indicated development, the RO should readjudicate the issues remaining on appeal in light of all the evidence of record. If any benefit sought on appeal remains denied, the Veteran and his representative should be furnished with a fully responsive SSOC and afforded a reasonable opportunity for response. The Veteran has the right to submit additional evidence and argument on the matters the Board has remanded. Kutscherousky v. West, 12 Vet.App. 369 (1999). This claim must be afforded expeditious treatment. The law requires that all claims that are remanded by the Board or by the Court for additional development or other appropriate action must be handled in an expeditious manner. See 38 U.S.C.A. §§ 5109B, 7112 (West Supp. 2013). ______________________________________________ H. N. SCHWARTZ Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs