ENERGEN™ ICD E142Recalls & reported problems

Summary

The FDA's MAUDE database contains 705 adverse event reports that list this exact device (DI 00802526480737), received between Oct 12, 2016 and Sep 17, 2026 — classified as 1 death, 531 injuries, 173 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (355 reports).

14 other recalls cover devices cleared under the same FDA submission (P960040); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 705 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) and right ventricular (RV) lead recorded a shock lead impedance of 10 ohms during a hospital check. Technical Services (TS) was consulted and noted this was likely due to electromagnetic interference (EMI) given the hospital environment. It was noted that the local company representative repeated the test and a measurement of 90 ohms was obtained. No further out of range measurements were noted. This ICD and RV lead remain in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797674 ↗
• InjurySep 16, 2026Failure to Convert Rhythm

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) had a ventricular tachycardia (VT) that require multiple shocks to be converted. Technical Services (TS) was consulted and discussed stored data since the patients physician was considering performing a defibrillation threshold (DFT) test. At a later date, a DFT was performed and it was successful This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792358 ↗
• InjurySep 11, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) had not had their device routinely checked and when the patient went in, the device had reached battery capacity depleted (BCD) status. It was noted shocks were delivered but it was not determined whether the shocks were appropriate. Subsequently, this ICD was explanted and successfully replaced. No additional adverse patient effects were reported. This ICD has not been returned for analysis.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50734696 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the health care professional (HCP) called Technical Services (TS) to notify them that this implantable cardioverter defibrillator (ICD) had been explanted. No additional information was provided. This ICD was successfully replaced with a non-Boston Scientific device. No additional adverse patient effects were reported. This ICD was returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690074 ↗
• MalfunctionSep 8, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673808 ↗
• MalfunctionSep 4, 2026Battery Problem

  It was reported that this implantable cardioverter defibrillator (ICD) had an anomaly regarding battery longevity as the patient was in questioned while being in the hospital. Boston Scientific Technical Services consultant (TS) referred the patient to the device following physician. At this time, this ICD remains in service. No adverse patient effects were reported.Additional information received indicates that this ICD has reached Elective Replacement Indicator and hospitalization was not related to our device. Subsequently, this ICD was explanted and was replaced with different model.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601125 ↗
• MalfunctionJul 21, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited high out of range (OOR) shock impedance measurements above 125 ohms. Technical Services (TS) recommended considering defibrillation threshold (DFT) testing, reprogramming options and continuing to monitor. No adverse patient effects were reporter. This device remains in service.Additional information was received that the cause of the rise in impedance measurements has not been determined at this time. No adverse patient effects were reported. This device remains in service.Further information was received indicating that this device was subsequently explanted and replaced. No additional adverse patient effects were reported. This device has been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894725 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25524940 ↗
• InjuryJun 3, 2026Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI), HOWEVER, THE PREVIOUS DEVICE CHECK SHOWED SIX MONTHS REMAINING. TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED THE DEVICE REACHED ERI DUE TO TWO EXTENDED CHARGE TIMES, WHICH WERE GREATER THAN 15 SECONDS. TS RECOMMENDED DEVICE REPLACEMENT. THIS ICD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THIS ICD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385231 ↗
• InjuryMay 15, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194637 ↗
• InjuryMay 13, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Data Problem

  IT WAS REPORTED THAT THIS THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SEVEN INAPPROPRIATE SHOCKS FOR RAPID VENTRICULAR RESPONSE (RVR) OVER FIVE EPISODES. OVER 20 VENTRICULAR EPISODES WERE STORED, AND ONLY TWO ELECTROGRAMS (EGMS) WERE STORED. DUE TO THE LARGE NUMBER OF EVENTS AND THE LONG DURATIONS OF THERAPY EVENTS, DEVICE MEMORY WAS FULL. THE SHOCK EVENTS ARE THE HIGHEST PRIORITY, AND THE DEVICE START STORING WHEN A NEW EVENT STARTS IN CASE IT ENDS WITH SHOCKS. AS A RESULT, THE PREVIOUS SHOCK EVENTS ARE OVERWRITTEN. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS, SUCH AS REDUCING THE NUMBER OF STORED NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EVENTS AND NO THERAPY EVENTS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURATION WAS EXTENDED TO MINIMIZE THE EPISODE STORAGE AND REDUCE THE LIKELIHOOD OF INAPPROPRIATE THERAPY. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164851 ↗
• InjuryApr 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO AN ADVISORY. THIS ICD WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH ANOTHER LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24948834 ↗
• MalfunctionApr 15, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED BY A PROGRAMMER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24892021 ↗
• MalfunctionApr 11, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS DEVICE EXHIBITED NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR (RV) CHANNEL WHICH RESULTED IN APPROXIMATELY 1.5 SECONDS. THE RV SENSITIVITY WAS REPROGRAMMED FROM .6 MV TO .9 MV. ADDITIONALLY, THE ATRIAL TACHYCARDIA RESPONSE (ATR) WAS INCREASED FROM 170 BPM TO 190 BPM AND THE MAXIMUM TRACKING RATE (MTR) WAS 150 BPM. THE PATIENT WAS ASYMPTOMATIC AND WILL CONTINUE TO BE FOLLOWED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS SUBSEQUENTLY REPLACED DUE TO NORMAL BATTERY DEPLETION AND RETURNED FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24846199 ↗
• InjuryMar 20, 2026High impedance; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO ADVISORY. ANOTHER DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650202 ↗
• MalfunctionMar 10, 2026Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXHIBITING FAR FIELD OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD THAT LED TO AN INAPPROPRIATE MODE SWITCH. TECHNICAL SERVICES (TS) REVIEWED AND SUGGESTED PROGRAMMING CHANGES FOR THIS DEVICE. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559709 ↗
• InjuryFeb 13, 2026High impedance; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO A PRODUCT PERFORMANCE ISSUE. THIS PACEMAKER WAS SUCCESSFULLY EXPLANTED AND A NEW LEAD IMPLANTED INSTEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS ICD WAS EXPLANTED RECORDED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) CHANNEL AND THE DEVICE WAS INCLUDED ON THE REVISION PROCEDURE AS IT WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335032 ↗
• InjuryFeb 13, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM PRESENTED TO THE EMERGENCY ROOM. AN INTERROGATION WAS PERFORMED. IT WAS FOUND THIS ICD HAD DELIVERED MULTIPLE ROUNDS OF INAPPROPRIATE ANTI-TACHYCARDIA PACING AND MULTIPLE INAPPROPRIATE SHOCKS DUE TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THERAPY WAS EXHAUSTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24333549 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED TIREDNESS AND AN EXPRESSION THAT HEAR WAS ABOUT TO JUMP OUT OF THE CHEST SINCE DEVICE ADJUSTMENTS. AS OF THIS TIME, THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 24295068 ↗
• InjuryFeb 3, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REACHING END OF LIFE (EOL) AND NEARED ELECTIVE REPLACEMENT INDICATOR (ERI). THE PHYSICIAN CLAIMED THE ICD DID NOT HAVE SUFFICIENT BATTERY TO OPERATE PROPERLY AND NEEDED REPLACEMENT. THE PHYSICIAN NOTED THE SHOCK LEAD IMPEDANCE FOR THE RIGHT VENTRICULAR (RV) LEAD WAS MEASURED AT 49 OHMS. TECHNICAL SERVICES (TS) ADVISED REPLACING THE LEAD AT THE DEVICE CHANGEOUT IS THE PHYSICIAN'S DISCRETION. THE PHYSICIAN WANTED THE ICD REPLACED, EVEN THOUGH ERI HAD NOT BEEN DECLARED. THE PHYSICIAN THEN INCREASED THE OUTPUTS OF THE LEADS TO FORCE ERI. THE ICD WAS EXPLANTED AND REPLACED. THE LEADS REMAIN IN SERVICE. THIS DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254022 ↗
• InjuryDec 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO OTHER/NON-PRODUCT EXPERIENCE. THIS ICD HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921645 ↗
• InjuryDec 3, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED OF DELIVERING INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SIX ELECTRIC SHOCKS DUE TO SINUS TACHYCARDIA. THERAPY DID NOT CONVERT THE RHYTHM AND WAS EXHAUSTED. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23705407 ↗
• MalfunctionDec 2, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE, AROUND 145 OHMS. IT WAS NOTED THIS ICD REACHED A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI). THIS ICD HAS BEEN IMPLANTED FOR 11 YEARS AND HAS REACHED EXPECTED LONGEVITY. TECHNICAL SERVICES (TS) RECOMMENDED REVISING THE LEAD DURING THE ICD EXPLANT PROCEDURE. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697161 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS DEFIBRILLATOR WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. REPORTEDLY, THE PATIENT HAD TRIGGERED THE ELECTIVE REPLACEMENT INDICATOR (ERI) OF THE DEFIBRILLATOR WHILE HAVING AN ACTIVE INFECTION. THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INFORMED ABOUT THE ERI AND END OF LIFE (EOL). THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE DEFIBRILLATOR WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23619426 ↗
• MalfunctionNov 19, 2025Battery Problem; Interrogation Problem; Battery Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A LOW BATTERY AND WAS UNABLE TO READ THIS ICD PRIOR TO REACHING OUT THE HEALTHCARE PROFESSIONAL BY A CONSULT. AS OF THIS TIME, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23599064 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960040. One submission often covers many models, so check the product and lot details in each record.

• Z-1670-2022 · Jul 7, 2022 · Open, Classified
  The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all
• Z-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, Sterile.
• Z-0079-2018 · Oct 4, 2017 · Terminated
  VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharma
• Z-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, Sterile.
• Z-1555-2010 · Mar 15, 2010 · Terminated
  Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and termina
• Z-0610-2010 · Dec 1, 2009 · Terminated
  Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethyle
• Z-1621-2009 · Mar 4, 2009 · Terminated
  GUIDANT VITALITY DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T175 VR; 2EL ICD Model T167 DR; 2 EL ICD Model T177 VR; DS Model T125 DR. Implantable Cardi
• Z-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• Z-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• Z-0051-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Guidant Corporation, 4100 Hamline A
• Z-0050-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant VITALITY DR HE (Model T180), Implantable Cardioverter Defibrillators (ICD). Guidant Corpor
• Z-1297-06 · Jun 24, 2006 · Terminated
  Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide.
• Z-1292-06 · May 15, 2006 · Terminated
  Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ven
• Z-0828-06 · Apr 7, 2006 · Terminated
  Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 551