ENERGEN CRT-DRecalls & reported problems across all models

We found 2 models of ENERGEN CRT-D by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 530 adverse event reports in the FDA's MAUDE database, received between Oct 28, 2013 and Mar 18, 2026 — classified as 4 deaths, 347 injuries, 179 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (140 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 CRT-D problems

ENERGEN CRT-D models

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

• ENERGEN™ CRT-D N140

  Implantable pulse generator, pacemaker (non-CRT)
  2 deaths301 reports
• ENERGEN™ CRT-D N141

  Implantable pulse generator, pacemaker (non-CRT)
  2 deaths229 reports

Recent ENERGEN CRT-D adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026High impedance; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED THE EXPLANT INDICATOR EARLIER THAN EXPECTED BASED ON PRIOR LONGEVITY ESTIMATES. TECHNICAL SERVICES (TS) REVIEWED THE DATA AND NOTED THAT THE EXPLANT INDICATOR WAS TRIGGERED DUE TO HIGH VOLTAGE CHARGE TIMES EXCEEDING 15 SECONDS ON MULTIPLE OCCASIONS. ENGINEERING ANALYSIS CONFIRMED THE DEVICE IS DEPLETING NORMALLY AND THAT THIS REPRESENTS A SECONDARY MECHANISM FOR REACHING ELECTIVE REPLACEMENT INDICATOR (ERI), NOT REFLECTED IN STANDARD LONGEVITY PROJECTIONS. A PRIOR HIGH OUT-OF-RANGE SHOCK IMPEDANCE ALERT WAS ALSO NOTED. DEVICE REPLACEMENT WITHIN THE NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) TO END-OF-LIFE WINDOW WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS CRT-D WAS SUCCESSFULLY EXPLANTED REACHED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627317 ↗
• InjuryJan 26, 2026Premature Discharge of Battery; Difficult to Remove; Noise, Audible

  IT WAS REPORTED THAT THE BATTERY OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SUSPECTED TO BE DEPLETING PREMATURELY. TONES WAS EMITTED. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. THIS CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177942 ↗
• MalfunctionNov 3, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT DURING A GENERATOR CHANGE DUE TO NORMAL BATTERY DEPLETION FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IT WAS OBSERVED THAT THE ATRIAL AND LEFT VENTRICULAR (LV) LEADS WERE INVERTED IN THE HEADER WHEN IMPLANTED BACK IN 2015. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS PRODUCT IS NOT EXPECTED TO BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452103 ↗
• InjuryJul 8, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IS SUSPECTED TO BE DEPLETING PREMATURELY AND REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER INDICATING MONTHS REMAINING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED LIKELY DUE TO CHARGE TIME (CT). THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22432820 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD EXHIBITED POSSIBLE INFECTION. REPORTEDLY, THE WAS PATIENT COMPLAINED OF A LARGE LUMP AT THE IMPLANT SITE AND STATED THAT THE DEVICE WAS SOMEWHAT STICKING UP. AS OF THIS TIME, THE CRT-D WITH THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 22116742 ↗
• MalfunctionApr 29, 2025Signal Artifact/Noise; Failure to Capture; Noise, Audible; Signal Artifact/Noise; Failure to Capture; Noise, Audible

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SUSPECTED TO HAVE INTERMITTENT LOSS OF CAPTURE (LOC) FOR ITS NON BOSTON SCIENTIFIC LEFT VENTRICULAR (LV) LEAD. THIS CRT-D HAS REACHED ELECTIVE REPLACEMENT INDICATOR (ERI), SO IT WAS BEEPING AS A RESULT. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA, WITH SOME NOISY SIGNALS NOTED FOR THE ASSOCIATED RIGHT ATRIAL (RA) LEAD. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928076 ↗
• InjuryApr 23, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL RISE IN SHOCK IMPEDANCE MEASUREMENTS, EVENTUALLY GOING OUT OF RANGE. TECHNICAL SERVICES (TS) SUSPECTED CALCIUM BUILD UP ON THE SHOCKING COIL. TS RECOMMENDED TROUBLESHOOTING OPTIONS AND REPLACING THE RV LEAD. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD THAT A COMMANDED SHOCK WAS PERFORMED. THE RV LEAD AND CRT-D HAVE NOT BEEN EXPLANTED. CALCIFICATION ON THE RV LEAD WAS NOT CONFIRMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THIS CRT-D WAS EXPLANTED AND REPLACED. THE RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891109 ↗
• InjuryApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THE ASSOCIATED RV LEAD WAS TAKEN OUT OF SERVICE; HOWEVER, THIS DEVICE REMAINED IN SERVICE AT THE TIME OF PROCEDURE AND WAS SUBSEQUENTLY REMOVED FROM SERVICE AT A LATER DATE TO AN UNRELATED REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862277 ↗
• InjuryApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861055 ↗
• InjuryApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859341 ↗
• MalfunctionApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854415 ↗
• MalfunctionApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854094 ↗
• MalfunctionApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853998 ↗
• MalfunctionApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853802 ↗
• InjuryApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. NO OTHER INFORMATION WAS PROVIDED. THIS RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853619 ↗

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