ENERGEN™ CRT-D N140Recalls & reported problems

Summary

The FDA's MAUDE database contains 301 adverse event reports that list this exact device (DI 00802526480959), received between Oct 28, 2013 and Mar 18, 2026 — classified as 2 deaths, 208 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (97 reports).

19 other recalls cover devices cleared under the same FDA submission (P010012); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 301 reports, 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 ↗
• 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 ↗
• 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 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 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 ↗
• MalfunctionFeb 6, 2025High impedance; Failure to Read Input Signal; Low impedance; High impedance; Failure to Read Input Signal; Low impedance

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS TO UNDERGO MAGNETIC RESONANCE IMAGING (MRI). TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THIS SYSTEM IS NON-CONDITIONAL DUE TO OUT-OF-RANGE IMPEDANCE MEASUREMENTS FOR ITS RIGHT ATRIAL (RA) LEAD AND LEFT VENTRICULAR (LV) LEAD. THE RA LEAD EXHIBITED LOW OUT OF RANGE IMPEDANCE MEASUREMENTS. THE LV LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. ADDITIONALLY, LOW AMPLITUDE WAS NOTED FOR ITS RA LEAD. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322789 ↗
• InjuryJan 30, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SUSPECTED TO BE DEPLETING PREMATURELY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING NORMALLY. TECHNICAL SERVICES STATED THAT LABELED RECOMMENDATIONS APPLY. SUBSEQUENTLY THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED. THIS PRODUCT HAS BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVENT PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277617 ↗
• MalfunctionJan 13, 2025Telemetry Discrepancy; Telemetry Discrepancy

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD DIFFICULTIES TO INTERROGATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144790 ↗
• MalfunctionNov 19, 2024Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED AN INAPPROPRIATE SHOCK DURING A SURGICAL PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20727278 ↗
• InjurySep 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Defibrillation/Stimulation Problem; Delayed Charge Time; Incorrect, Inadequate or Imprecise Result or Readings; Defibrillation/Stimulation Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) VISITED THE EMERGENCY ROOM (ER) AFTER REPORTING THEY HAD RECEIVED SIX SHOCKS. UPON INTERROGATION IT WAS NOTED THAT THE DEVICE RECORDED A CODE 1007 TRIGGERED INDICATIVE OF CAPACITOR CHARGE TIME EXCEEDING LIMITATIONS. THE CHARGE TIME WAS FOUND TO BE GREATER THAN 45 SECONDS. IT WAS FURTHER NOTED THAT THIS CRT-D HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS APPROXIMATELY THREE MONTHS PRIOR. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED DEVICE REPLACEMENT AS THERAPY COULD NOT BE GUARANTEED, AS WELL AS A REVIEW OF THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD INTEGRITY AT DURING REPLACEMENT. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20317366 ↗
• InjurySep 13, 2024High impedance; Noise, Audible; High impedance; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM HEARD BEEPING TONES FROM THE DEVICE. BATTERY LONGEVITY IS AT EIGHT MONTHS. TECHNICAL SERVICES (TS) REVIEWED DEVICE DATA AND FOUND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS MEASURING GREATER THAN 2,000 OHMS BACK IN MAY. TS RECOMMENDED CHECKING THE DEVICE AND CLEARING THE TONES. AT THIS TIME, THE DEVICE AND NON-BOSTON SCIENTIFIC LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED, AND THE NON-BOSTON SCIENTIFIC LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED. IT WAS NOTED THAT THE LV HAD ABRUPT CHANGES IN PACING LEAD IMPEDANCES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211844 ↗
• MalfunctionAug 14, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED ONE INAPPROPRIATE SHOCK DUE TO ATRIALLY DRIVEN VENTRICULAR RHYTHM. NO OTHER INFORMATION WAS PROVIDED. APPROXIMATELY SEVEN YEARS AFTER BEING IMPLANTED, THIS CRT-D WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19987945 ↗
• InjuryAug 12, 2024Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR REPLACEMENT PROCEDURE, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS OBSERVED TO HAVE SETSCREW DAMAGE. THE PHYSICIAN REPORTED EXPERIENCING DIFFICULTIES DISCONNECTING THE OLD LEFT VENTRICULAR (LV) LEAD. FURTHER INSPECTION OF THE CRT-D DEVICE SHOWED SET SCREW DAMAGE. THE PHYSICIAN DECIDED TO SURGICALLY ABANDON THE LV LEAD AND EXPLANTED THE CRT-D DEVICE. THE LV LEAD AND THE CRT-D WERE SUCCESSFULLY REPLACED WITH NEW A LEAD AND DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960891 ↗
• MalfunctionJul 8, 2024Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD). DURING THE PROCEDURE, THE DEVICE WAS PROGRAMMED INTO ELECTROCAUTERY MODE AND PACING INHIBITION WAS OBSERVED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THIS WAS LIKELY DUE TO DEFIB DETECT CIRCUIT THAT CAN BE TRIGGERED EVEN IN ELECTROCAUTERY MODE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS SUCCESSFULLY REPLACED. AT THIS TIME, IT IS UNKNOWN IF THIS DEVICE WILL RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697312 ↗
• MalfunctionMay 27, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT DURING THE REPLACEMENT PROCEDURE OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO NORMAL BATTERY DEPLETION (NBD), OVERSENSING OF ELECTROMAGNETIC INTERFERENCE (EMI) OR ELECTROCAUTERY WAS OBSERVED. AS A RESULT, THE PATIENT EXPERIENCED PACING INHIBITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, IT IS UNKNOWN IF THIS DEVICE WILL RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402254 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 19212028 ↗
• InjuryMar 26, 2024Extracardiac stimulation; Extracardiac stimulation

  IT WAS REPORTED THAT PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED "STIMULATION IN THE POCKET" SINCE IMPLANT. FURTHERMORE, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 18984322 ↗
• MalfunctionMar 6, 2024Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER AS EXPECTED. THIS DEVICE WENT FROM 1.5 YEARS TO ERI IN JUST THREE MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) THEN SUGGESTED CLOSE MONITORING WITH THE DEVICE CHARGE TIME TO DETERMINE IF IT IS NEARING 15 SECONDS OR SLOWING EXTENDING. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844695 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 18747228 ↗
• MalfunctionJan 16, 2024Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS SYSTEM WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS SHOWED A GRADUAL INCREASE IN LV PACING IMPEDANCES FROM WITHIN RANGE VALUES TO HIGH, OUT OF RANGE AT THE TIME OF THE CALL. ALSO, THERE WAS NON-SUSTAINED VENTRICULAR TACHYCARDIA WITH FINE NOISE ON THE RV CHANNEL WITH NO PAUSES GREATER THAN TWO SECONDS. TECHNICAL SERVICES RECOMMENDED ISOMETRICS WITH POCKET MANIPULATION, COUGHING AND DEEP BREATHING WHILE SAMPLING IMPEDANCE. THE PATIENT IS PACING DEPENDENT BUT NO SYMPTOMS POST-SURGICAL PRODUCED AND THEY WERE NOT ABLE TO DO THE TESTING AT THE MOMENT. THE CRT-D, RV AND LV LEADS REMAIN IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515466 ↗
• InjuryDec 19, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED END-OF-LIFE (EOL) STATUS, BUT GENERATOR CHANGE COULD NOT BE DONE A WEEK OR SO FOR OTHER CIRCUMSTANCES. THE PATIENT IS DEPENDENT AND GOT A LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND SUDDENLY DEVELOPED A FOCAL PREMATURE VENTRICULAR CONTRACTIONS WHICH WOULD SET OFF INTO A TERRIBLE COURSE OF VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) AND GOT SHOCK MANY TIMES THAT CAUSED THE BATTERY TO DEPLETE. THE PATIENT WAS ON MEDICATION BUT COULD NOT DO ANYTHING ABOUT IT. ADDITIONALLY, THE PATIENT'S RATE HAS DROPPED FROM 80 TO 50. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) STATED THAT WITH A BATTERY STATUS OF EOL AT THIS POINT, WE CAN NO LONGER GUARANTEE PACING THERAPY. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354255 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010012. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2022 · 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-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-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• Z-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-1556-2010 · Mar 15, 2010 · Terminated
  Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillat
• Z-0609-2010 · Dec 1, 2009 · Terminated
  Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107,
• Z-1052-2007 · Mar 23, 2007 · Terminated
  VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. P
• Z-1047-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North,
• Z-1055-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are design
• Z-1049-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
• Z-1053-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventric
• Z-1054-2007 · Mar 23, 2007 · Terminated
  VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 U
• Z-0047-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.
• Z-1288-06 · May 15, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave
• Z-0827-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55

…and 4 more.