INCEPTA™ CRT-D N164Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 00802526481031), received between May 8, 2014 and Feb 11, 2026 — classified as 1 death, 67 injuries, 28 malfunctions.

The most frequently reported specific device problem is “High impedance” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED AN ALERT AND WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316703 ↗
• InjurySep 2, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THERAPIES WERE TURNED OFF SPECIFICALLY BRADY AND TACHY THERAPIES. AS OF THIS TIME, THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939175 ↗
• InjuryMay 28, 2025Adverse 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 THE SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22093624 ↗
• 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. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853499 ↗
• MalfunctionMar 11, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED NOISE OVERSENSING ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE NOISE SEEMED TO BE MYOPOTENTIAL. ALL OTHER MEASUREMENTS WERE IN RANGE. FURTHER TESTING WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D WAS LATER EXPLANTED DUE TO NORMAL BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574141 ↗
• MalfunctionAug 13, 2024Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; 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) EXHIBITED INAPPROPRIATE SHOCKS DUE TO NOISE AND OVERSENSING IN THE RIGHT VENTRICULAR (RV) CHANNEL. 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 19974437 ↗
• InjuryJul 1, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THERE WERE CONCERNS THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE THERAPY. THIS DEVICE DELIVERED TREE BURSTS OF ANTI-TACHYCARDIA PACING (ATP) AND FOUR SHOCKS. THE THERAPY WAS BELIEVED TO BE A RESULT OF SUPRAVENTRICULAR TACHYCARDIA (SVT). THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE DEVICE WAS USCCESFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19645129 ↗
• MalfunctionMay 20, 2024High impedance; Failure to Read Input Signal; High impedance; Failure to Read Input Signal

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE EXHIBITED HIGH IMPEDANCE MEASUREMENTS ON THE LEFT VENTRICULAR (LV) CHANNEL. UPON REVIEW, TECHNICAL SERVICES (TS) STATED THAT THERE WAS AN ABRUPT RISE IN THE IMPEDANCES WITH MEASUREMENTS AT 1425 OHMS. THERE WAS ALSO DECREASE IN INTRINSIC AMPLITUDE WHICH WERE NOTED HIGH EARLIER. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351860 ↗
• InjuryNov 28, 2023Signal Artifact/Noise; Failure to Capture; High impedance; Signal Artifact/Noise; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE ON THE LEFT VENTRICULAR (LV) CHANNEL. ADDITIONALLY, THE DEVICE EXHIBITED LOSS OF CAPTURE (LOC) AND NON-PHYSIOLOGIC NOISY SIGNALS ON THE LV CHANNEL. THE SIGNALS WERE NOT OVERSENSED. THE DEVICE WAS EXPLANTED AND REPLACED WITH A DOWNGRADED DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18219825 ↗
• InjuryNov 16, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT, DURING A NORMAL BATTERY DEPLETION REPLACEMENT. WHILE THE LEFT VENTRICULAR LEAD WAS BEING EXTRACTED, THE INSULATION OF THE LEAD WAS DAMAGED. ADDITIONALLY, IT WAS NOTED THAT THE LEAD PIN GOT STUCK IN THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HEADER. THE PIN WAS ABLE TO BE RETRIEVED, HOWEVER, IT WAS DECIDED TO CUT THE LEAD AND SURGICALLY ABANDON IT. ANOTHER DEVICE SYSTEM WAS IMPLANTED INSTEAD AND FURTHER DISCUSSION OF A THERAPY UPGRADE IN THE FUTURE WAS PERFORMED. THIS DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18150975 ↗
• MalfunctionJul 27, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THIS RIGHT VENTRICULAR (RV) LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND REPROGRAMMING OPTIONS WERE DISCUSSED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410190 ↗
• InjuryMay 24, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS CONFIRMED LOW VOLTAGE FAULT. MOREOVER, IT WAS NOTED THAT THE DEVICE HARDWARE WAS NOT DETECTING THE LOSS OF BATTERY ENERGY. THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION AND ARE INACCURATE WHICH SHOULD NO LONGER BE RELIED IN DETERMINING THE DEPLETION STATUS OF THE DEVICE. FURTHERMORE, THE DEVICE WAS MALFUNCTIONING AND SHOULD BE REPLACED THEN RETURN FOR A DETAILED ANALYSIS. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE CHANGEOUT WAS NOT YET SCHEDULED AS PATIENT HAD OSTEOMYELITIS WHICH IS NOT DEVICE RELATED AND WAS WAITING FOR THE INFECTION TO CLEAR PRIOR TO SCHEDULING THE CHANGEOUT. ALSO, THE DEVICE HAS TRIPPED EXPLANT. THIS DEVICE REMAINS IN SERVICE, AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990776 ↗
• InjuryMay 22, 2023Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISE ON THE RIGHT ATRIAL CHANNEL. FURTHER EVALUATION OF THE PATIENT WAS DISCUSSED. THIS DEVICE REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED DETAILING THAT THIS DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16980011 ↗
• InjuryJan 4, 2023Adverse 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 POCKET INFECTION AND EROSION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 16098663 ↗
• InjuryDec 23, 2022Signal Artifact/Noise; Over-Sensing; Pacing Problem; Low impedance; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Low impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISY SIGNALS, OVERSENSING, AND PACING INHIBITION GREATER THAN 2 SECONDS ON THE RIGHT VENTRICULAR (RV) LEAD. ADDITIONALLY, IT WAS NOTED A VERY GRADUAL DECREASE IN RV PACING AND SHOCK IMPEDANCE MEASUREMENTS. TROUBLESHOOTING OPTIONS WERE DISCUSSED. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 16043279 ↗
• InjuryJul 14, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM HAD BEEN EXPERIENCING JUMPS IN RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCES FROM 800 OHMS TO 1600 OHMS. THE REPRESENTATIVE WANTED TO KNOW IF THIS JUMPS COULD RELATE TO A LEAD ISSUE, TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED THE CASE AND NOTED THERE WAS NO EVIDENCE OF A FRACTURED LEAD OR AN ISSUE WITH LEAD INTEGRITY. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15020707 ↗
• InjuryApr 26, 2022Difficult to Remove; Connection Problem; Material Integrity Problem; Difficult to Remove; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. REPORTEDLY, IN THE SAME REPLACEMENT PROCEDURE, THE NON-BSC RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE EXPLANTED DUE TO NOISY SIGNALS. THE RA LEAD WAS STUCK IN THIS DEVICE HEADER AND HAD TO BE CUT TO BE REMOVED. SUBSEQUENTLY, THIS CRT-D WAS SUCCESSFULLY REPLACED, IT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14212093 ↗
• MalfunctionApr 13, 2022Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) IN SEVERAL EPISODES. TACHYCARDIA THERAPY WAS REPORTED TO HAVE BEEN EXHAUSTED IN ONE OF THE STORED EPISODES. ADDITIONALLY, OVERSENSING OF NOISE WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. PROGRAMMING CHANGES WERE MADE TO ATRIAL SENSITIVITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Electric Shock

  MAUDE report 14108219 ↗
• DeathApr 13, 2022Adverse 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) CONTRACTED A (B)(6) INFECTION WHICH TRAVELED TO THE DEVICE. THE PATIENT WAS BEING PREPARED FOR A DEVICE EXPLANT WHEN THEY PASSED AWAY. IT WAS NOTED THAT THE PATIENT WAS UNABLE TO WITHSTAND THE ANESTHESIA. THE DEVICE WAS NOT REMOVED.

  Patient problems: Bacterial Infection

  MAUDE report 14106732 ↗
• MalfunctionApr 9, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED WITHOUT INCIDENT, DUE TO NORMAL BATTERY DEPLETION. UPON RETURN TO BOSTON SCIENTIFIC AFTER EXPLANTATION, A DETAILED ANALYSIS CONFIRMED PREMATURE BATTERY DEPLETION. IT WAS DETERMINED THAT THE LOW VOLTAGE CAPACITORS WERE COMPROMISED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14067902 ↗
• MalfunctionFeb 4, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED EXPLANT EARLIER THAN EXPECTED. ENGINEERING ANALYSIS DETERMINED THAT THIS DEVICE DID NOT DECLARE LOW VOLTAGE FAULT, HOWEVER DEVICE WAS DEPLETING IN A MANNER CONSISTENT WITH THE LV CAPACITORS ADVISORY. IN ADDITION, THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY AND WITH THIS THE BATTERY STATUS INDICATORS WERE NOT REFLECTING THE DEPLETION CONDITION AND WERE INACCURATE. HENCE, SHOULD NOT BE RELIED UPON TO DETERMINED THE DEPLETION STATUS OF THIS DEVICE. TO DATE, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13461916 ↗
• MalfunctionJan 27, 2022High impedance; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing; Noise, Audible; High impedance; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing; Noise, Audible

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INAPPROPRIATELY DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SIX SHOCKS DUE TO SUPRAVENTRICULAR TACHYCARDIA (SVT). THE VENTRICULAR RHYTHM SURPASSED THE ATRIAL RHYTHM DUE TO CROSS CHAMBER BLANKING. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND THIS CRT-D IS EXHIBITING BEEPING. TECHNICAL SERVICES (TS) WAS CONSULTED AND FOUND HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) RECOMMENDED TO CONTINUE TO MONITOR THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 13376321 ↗
• InjuryNov 2, 2021Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE WAS EXHIBITING OVERSENSING OF THE RESPIRATORY RATE TREND (RRT) SENSOR. BOSTON SCIENTIFIC TECHNICAL SERVICES WALKED THE BOSTON SCIENTIFIC REPRESENTATIVE THROUGH HOW TO PROGRAM THE RRT SENSOR OFF ON THIS DEVICE PRODUCT FAMILY. NO OTHER DETAILS WERE PROVIDED. IN ADDITION, THERE WERE INTERMITTENT HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD IMPEDANCE TREND. THE PRODUCTS REMAIN IN-SERVICE. NO PATIENT SYMPTOMS OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741913 ↗
• InjuryOct 22, 2021Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS SYSTEM EXHIBITED NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR CHANNEL. A REVISION PROCEDURE WAS PERFORMED AND THE SYSTEM WAS REMOVED FROM SERVICE AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686455 ↗
• InjuryOct 19, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT UPON THIS PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR EXPLANT PROCEDURE, IT WAS SWITCHED INTO ELECTROCAUTERY MODE, HOWEVER, PACING INHIBITION WAS NOTED DURING THE BURST OF ELECTROCAUTERY. THE DEVICE WAS REPROGRAMMED TO ANOTHER SETTING AND THE ISSUE REMAINED. TECHNICAL SERVICES (TS) REVIEW THIS CASE AND STATED THAT THIS BEHAVIOR WOULD ONLY BE EXPECTED IF THE COMMAND WAS NOT RECEIVED BY THE DEVICE OR IF CHANGES NOT APPLIED. ELECTROCAUTERY MODE SCREEN WAS CONFIRMED. TS ASKED IF COULD SEND SCREENSHOT OF THE SCREEN, BUT THIS WAS UNAVAILABLE. THE CALLER SALES REPRESENTATIVE INDICATED THE PLAN WAS TO CONNECT A BACKUP PACING SUPPORT. FURTHER INFORMATION WAS RECEIVED, THE PATIENT SUFFERED MORE THAN 2 SECONDS OF ASYSTOLE DUE TO THIS ISSUE. THE BACKUP PACING SUPPORT WORK ADEQUATELY AND THE PROCEDURE WAS CARRIED ON SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 12662520 ↗

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-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-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-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-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-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-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-0826-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Ha

…and 4 more.