ENERGEN™ ICD E140Recalls & reported problems

Summary

The FDA's MAUDE database contains 819 adverse event reports that list this exact device (DI 00802526480713), received between Jul 9, 2013 and Sep 30, 2026 — classified as 3 deaths, 636 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (490 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 819 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Premature Discharge of Battery; Battery Problem

  It was reported that the battery of this implantable cardioverter defibrillator (ICD) was thought to be depleting prematurely. The device showed one year remaining just one month ago, and upon interrogation the Elective Replacement Indicator (ERI) was reached. This ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946992 ↗
• InjurySep 24, 2026Insufficient Device Problem Information

  It was reported that this implantable cardioverter defibrillator (ICD) was explanted due to unknown reasons. This ICD was successfully replaced with a non-Boston Scientific device. Additional information was requested but unable to be obtained at this time. No additional adverse patient effects were reported. This ICD was returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882478 ↗
• MalfunctionSep 16, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796834 ↗
• InjurySep 4, 2026Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation; Use of Device Problem

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) presented to the emergency room (ER) and claimed they received shocks. It was noted the patient had been non-compliant, and data showed the device reached Elective Replacement Indicator (ERI) approximately eight months ago. It was also noted remote monitoring was disabled approximately three months ago. Technical Services (TS) reviewed the data and confirmed the device was at End of Life (EOL) and there would be no way to see whether the patient received therapy. It was not determined whether the patient was shocked, and whether therapy was appropriate or not. Information from the field was received and noted there was a fracture in the right ventricular (RV) lead and that the patient may have received inappropriate shocks due to the noise on the lead from the fracture. It was also noted both brady and tachy therapy was turned off. The patient was scheduled to follow up with the physician. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50602279 ↗
• MalfunctionSep 4, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602260 ↗
• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602134 ↗
• MalfunctionAug 25, 2026High impedance

  It was reported that this right ventricular (RV) and this Implantable Cardioverter Defibrillators (ICD) lead exhibited a gradual increase in shocking impedance, reaching a high out of range measurement of 128 Ohms. Technical Services discussed the option of changing the shocking lead impedance alert threshold to 150 Ohms and continuing to monitor lead performance. It was also discussed that if the shocking lead impedance exceeds 150 Ohms, lead replacement should be considered. The RV lead and the ICD remain in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50424459 ↗
• MalfunctionAug 19, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329801 ↗
• InjuryAug 4, 2026Pacing Problem

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) presented with a heart rate in the 30s. Device review confirmed appropriate ventricular pacing at the programmed lower rate limit of 40 bpm. Two nonsustained ventricular episodes below the therapy zone were identified, although the single-chamber device could not differentiate ventricular tachycardia from atrial fibrillation with rapid ventricular response. The healthcare provider reported externally converting the arrhythmia, and the device was determined to be operating as programmed. This device remains in service.

  Patient problems: Bradycardia

  MAUDE report 50135787 ↗
• MalfunctionAug 3, 2026Insufficient Device Problem Information; Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122138 ↗
• MalfunctionJul 14, 2026Interrogation Problem

  It was reported that the implantable cardioverter defibrillator (ICD) was unable to be interrogated. Technical Services (TS) was consulted and confirmed that the device was compatible; however, interrogation remained unsuccessful. TS believed the device is likely at End of Life, or the device was previously explanted, and a Boston Scientific device was no longer implanted. No confirmation is available if the device was explanted and replaced. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25815533 ↗
• MalfunctionJul 10, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REVIEWED AT END OF LIFE (EOL) AND A HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE ALERT WAS FOUND ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WERE NO DAILY MEASUREMENTS TO REVIEW FOR OTHER FAULTS. THE ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25788504 ↗
• MalfunctionJul 2, 2026Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD AN ALERT FOR A LOW OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT OF 0. DATA ANALYSIS SUGGESTS THIS WAS LIKELY A FALSE READING, AS THE SHOCK IMPEDANCE CANNOT BE 0 OHMS. HISTORICALLY FOR THE PATIENT, SHOCK IMPEDANCES WERE STABLE IN THE 50 OHMS RANGE. REVIEW OF REMOTE MONITORING DATA CONFIRMED THAT SUBSEQUENT SHOCK IMPEDANCE MEASUREMENTS WERE ALSO IN THE 50 OHMS RANGE. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700158 ↗
• InjuryJul 1, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD EXHIBITED INFECTION. A REVISION WAS PERFORMED AND THE ICD WAS EXPLANTED WHILE THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED. THERE WAS OVERSENSING AND UNDERSENSING NOTED ON THE STORED EPISODES. THIS DEVICE WAS NOT RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 25682391 ↗
• InjuryJun 23, 2026Unexpected Therapeutic Results; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM PRESENTED TO THE EMERGENCY ROOM (ER) DUE TO CARDIAC ARREST. ADDITIONALLY, THE DEVICE CLOCK DID NOT APPEAR TO HAVE ADJUSTED TO DAYLIGHT SAVINGS TIME. ELECTROGRAM (EGM) REVIEW REVEALED VENTRICULAR FIBRILLATION (VF) UNDERSENSING, INSTANCES WHERE THE ARRHYTHMIA WAS BELOW THE RATE CUTOFF (RCO), AND ANTI-TACHYCARDIA PACING (ATP) WAS INEFFECTIVE. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS; THE PATIENT WAS REFERRED TO CARDIOLOGY FOR THE CLINICAL DECISION OF ARRHYTHMIA INTERPRETATION AND NEXT STEPS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 25589176 ↗
• MalfunctionJun 10, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS OF 136 OHMS. TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED POSSIBLE REPROGRAMMING OPTIONS. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461054 ↗
• MalfunctionMay 4, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POSSIBLE UNDERSENSING. TECHNICAL SERVICES (TS) WAS CONTACTED BY THE HEALTH CARE PROFESSIONAL (HCP) FOR PACING SPIKES AFTER THE INTRINSIC R WAVE, WITH THE HCP REQUESTING THAT THE LOCAL FIELD REPRESENTATIVE REVIEW THE TELEMETRY STRIPS TO CLARIFY IF THE DEVICE IS PRESENTING AN ANOMALY OR NOT. TS NOTED THAT THE PRESENTING ELECTROGRAM SHOWS INTRINSIC ACTIVITY ONLY, AND THAT THE DEVICE IS FUNCTIONING AS PROGRAMMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067462 ↗
• InjuryApr 23, 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 24969048 ↗
• InjuryApr 17, 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 POSSIBLE EROSION AND INFECTION. THE DEVICE WAS POKING OUT. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD REMAINS IN SERVICE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 24909706 ↗
• InjuryMar 31, 2026High impedance

  IT WAS REPORTED THAT THIS SYSTEM WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AS THE RV LEAD HAD BEEN SHOWING HIGH, OUT OF RANGE SHOCK IMPEDANCES. A NEW SYSTEM WAS IMPLANTED, AND THE ICD HAS BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24738577 ↗
• MalfunctionMar 13, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) system exhibited shock impedance measurements high out of range on the right ventricular (RV) lead. Technical Services (TS) reviewed and provided assistance. This product remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594014 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD TWITCHING AND SPASMING IN TORSO AND PATIENT ADVOCATE WAS UNSURE IF IT WAS FROM DEVICE OR IF THE LEAD BECAME LOOSE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REFERRED PATIENT TO HEALTH CARE PROFESSIONAL (HCP). THIS DEVICE REMAINS IN SERVICE. ADDITIONAL INFORMATION WHICH INDICATING THAT THIS DEVICE WAS EXPLANTED. A NEW DEVICE WAS THEN IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Inappropriate Device Stimulation of Tissue; Twitching; Undesired Nerve Stimulation

  MAUDE report 24513647 ↗
• MalfunctionFeb 19, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED SHOCK IMPEDANCE HIGH OUT OF RANGE. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390114 ↗
• MalfunctionJan 27, 2026High impedance; Off-Label Use

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED FOR ASSISTANCE WITH PROGRAMMING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INTO MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE. TECHNICAL SERVICES (TS) INFORMED THIS IS A NON-CONDITIONAL SYSTEM DUE TO HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS AND PROGRAMMED THIS ICD. AFTER THE MRI WAS PERFORMED, THIS ICD SYSTEM WAS REMOVED FROM THE MRI PROTECTION MODE, IT WAS CONFIRMED THAT THE DEVICE WAS FUNCTIONING AS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194584 ↗
• MalfunctionJan 27, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A BLINKING RED CALL DOCTOR LIGHT. TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO THEIR CLINIC TO FURTHER REVIEW. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194525 ↗

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-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, 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-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-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-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-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