ENERGEN ICDRecalls & reported problems across all models

We found 4 models of ENERGEN ICD by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 2,322 adverse event reports in the FDA's MAUDE database, received between Jul 9, 2013 and Sep 30, 2026 — classified as 5 deaths, 1,761 injuries, 556 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (1,269 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ENERGEN ICD problems

ENERGEN ICD models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ENERGEN™ ICD E140

  Implantable pulse generator, pacemaker (non-CRT)
  3 deaths819 reports
• ENERGEN™ ICD E142

  Implantable pulse generator, pacemaker (non-CRT)
  1 death705 reports
• ENERGEN™ ICD E143

  Implantable pulse generator, pacemaker (non-CRT)
  1 death430 reports
• ENERGEN™ ICD E141

  Implantable pulse generator, pacemaker (non-CRT)
  368 reports

Recent ENERGEN ICD adverse event reports

The 15 most recent reports across all models, 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 25, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905816 ↗
• 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 ↗
• InjurySep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50823282 ↗
• 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 ↗
• MalfunctionSep 16, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796834 ↗
• 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 ↗
• MalfunctionSep 14, 2026Signal Artifact/Noise; Over-Sensing; Low impedance

  It was reported that this implantable cardioverter defibrillator (ICD) system exhibited oversensing of noisy signals for its right ventricular (RV) lead. Technical Services (TS) was consulted and reviewed stored data data. TS discussed stored data, with a decrease in impedance measurements for the RV lead. The impedance measurements were still within range. TS suspected a lead integrity issue based on the age of the RV lead. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755481 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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