INCEPTA™ CRT-D N161Recalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 00802526481000), received between Oct 12, 2016 and Jan 26, 2026 — classified as 2 deaths, 103 injuries, 63 malfunctions.

The most frequently reported specific device problem is “High impedance” (42 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 168 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED OVERSENSED NOISE ON THE RIGHT ATRIAL (RA) CHANNEL, RESULTING IN INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183504 ↗
• InjuryDec 20, 2025Delayed Charge Time; Battery Problem; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WITH 8 MONTHS OF REMAINING LONGEVITY, HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AND IS NOW AT END OF LIFE (EOL). TECHNICAL SERVICES (TS) REVIEWED THE CASE AND CONFIRMED THAT ERI WAS TRIGGERED DUE TO CHARGE TIME (CT). TS ALSO STATED THAT THE PATIENT LIKELY EXPERIENCED A CONNECTION PROBLEM; OTHERWISE, THE ALERT WOULD HAVE BEEN SENT VIA LATITUDE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860155 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23386396 ↗
• InjuryOct 8, 2025High impedance; Inappropriate/Inadequate Shock/Stimulation; High impedance; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCK THERAPY WITH NO THERAPY EXHAUSTION. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS, WHICH WERE REPRODUCIBLE VIA PACING SYSTEM ANALYZER (PSA) TESTING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS ICD DELIVERED INAPPROPRIATE SHOCK FOR EITHER SINUS TACHYCARDIA OR SUPRAVENTRICULAR TACHYCARDIA. THE RHYTHM WAS 1:1 AND ATRIAL DRIVEN. A SUBSEQUENT INAPPROPRIATE SHOCK WAS OBSERVED AT THE TIME OF REPORT. TECHNICAL SERVICES (TS) RECOMMENDED THAT THE HEALTH CARE PROFESSIONAL (HCP) CONSULT WITH CARDIOLOGY FOR FURTHER EVALUATION AND REPROGRAMMING OPTIONS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23243531 ↗
• InjuryAug 20, 2025Delayed Charge Time; Battery Problem; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A LONGEVITY OF 11 MONTHS AND DROPPED TO ELECTIVE REPLACEMENT INDICATOR (ERI) IN A SPAN OF 2 MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONFIRMED THAT THE DEVICE HAD A CAPACITOR REFORM AND CHARGE TIME (CT) EXCEEDED 15 SECONDS. THE CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED. A NEW CRT-D WITH A DIFFERENT MODEL WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22857377 ↗
• InjuryJun 5, 2025Signal Artifact/Noise; Premature Discharge of Battery; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Premature Discharge of Battery; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS PREVIOUSLY IMPLANTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM HAD A FRACTURED RIGHT VENTRICULAR (RV) LEAD WHICH EXHIBITED NOISE WITH OVERSENSING AND DELIVERED INAPPROPRIATE TACHY THERAPY. ADDITIONALLY, THIS LEAD ISSUE RESULTED IN INCREASED BATTERY POWER CONSUMPTION. IT WAS NOTED THAT THIS LEAD ISSUE OCCURRED BACK IN 2020, WHEN IT WAS DIFFICULT TO FIND AN AVAILABLE HOSPITAL ROOM IN ORDER FOR THE PATIENT TO UNDERGO A LEAD REVISION. IT WAS BELIEVED THAT THE PATIENT HAD FIVE LEADS IN HIS BODY AT ONE POINT. SOME OF THOSE LEADS HAD BEEN REVISED, AND A DEFIBRILLATION LEAD HAD BEEN IMPLANTED FOR A DEVICE WITH THREE LEADS. AS A RESULT OF THESE ISSUES, THE PATIENT REPORTED SEVERE DISCOMFORT/PAIN/DISTRESS. THIS CRT-D WAS EXPLANTED AND REPLACED WITH A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DURING A THERAPY DOWNGRADE, AND ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE AT THAT TIME MENTIONED THAT THE PATIENT NO LONGER NEEDED A DEFIBRILLATOR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D WAS RETURNED FOR ANALYSIS.

  Patient problems: Discomfort; Pain; Shock from Patient Lead(s)

  MAUDE report 22150657 ↗
• MalfunctionJun 4, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS REACHED EXPLANT INDICATOR AND EXHIBITED OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS. THE PLAN FOR THIS PATIENT IS CONTINUED MONITORING. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143563 ↗
• 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 21860579 ↗
• 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 21860098 ↗
• 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 21856101 ↗
• 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 21854800 ↗
• InjuryMar 25, 2025Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WENT OFF FIVE TIMES. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REFERRED PATIENT TO THE CLINIC. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED WHICH INDICATING THAT THIS DEVICE WAS EXPLANTED. A NEW DEVICE WAS THEN IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689263 ↗
• MalfunctionOct 22, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING OF NOISY SIGNALS. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THE STORED EPISODES. NO ADDITIONAL DEVICE ISSUES WERE NOTED. THIS CRT-D WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. A NEW DEVICE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20508124 ↗
• InjurySep 3, 2024Defective Device; Battery Problem; Defective Device; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS 8 MONTHS REMAINING AND CURRENTLY TRIPPED TO ELECTIVE REPLACEMENT INDICATOR (ERI). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) STATED THAT THIS WAS A SECONDARY MECHANISM FOR TRIGGERING EXPLANT AND THE CHARGE TIME HAS BEEN GRADUALLY RISING. AS OF THIS TIME, THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130068 ↗
• MalfunctionJul 31, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM OVERSENSED NOISE ON THE RIGHT VENTRICULAR (RV) LEAD, WHICH RESULTED IN PACING INHIBITION AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). THE PATIENT EXPERIENCED GREATER THAN TWO SECONDS OF ASYSTOLE. TECHNICAL SERVICES (TS) REVIEWED THE STORED EPISODES AND NOTED THE NOISE WAS SUGGESTS OF ELECTROMAGNETIC INTERFERENCE (EMI), HOWEVER, THE CAUSE OF THE EMI IS UNKNOWN. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT WAS SEEN IN CLINIC DUE TO THE RECURRENCE OF EMI SUGGESTIVE EPISODES. THE PATIENT BROUGHT IN THEIR CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) MACHINE; HOWEVER THE NOISE WAS UNABLE TO BE REPRODUCED. IT WAS SPECULATED THAT THE DEVICE COULD BE SENSING ATRIAL SIGNALS, BUT NOT CONFIRMED. IT WAS NOTED THAT NO FURTHER ACTION WOULD BE TAKEN AT THIS TIME. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 19878713 ↗
• MalfunctionJul 17, 2024Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT PROCEDURE DUE TO NORMAL BATTERY DEPLETION (NBD), THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) RESULTING IN ASYSTOLE GREATER THAN TWO SECONDS. THE PACING WAS RESUMED IMMEDIATELY WHEN THE RV WAS INSERTED BACK INTO THE HEADER OF THE DEVICE. THE INVOLVED RV LEAD IS A NON BOSTON SCIENTIFIC PRODUCT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. IT IS NOT EXPECTED TO RECEIVE THIS DEVICE FOR ANALYSIS.

  Patient problems: Asystole

  MAUDE report 19767831 ↗
• InjuryJul 9, 2024Premature Discharge of Battery; Noise, Audible; Premature Discharge of Battery; Noise, Audible

  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. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) THEN ADVISED TO SEND DATA FOR ANALYSIS AND ASSISTED IN SAVING DATA TO PROGRAMMER THEN EXPORTING DATA. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ENGINEERING ANALYSIS RESULT SHOWED THAT THE POWER OF THIS DEVICE HAD A COUPLE RECENT POWER INCREASE, INCLUDING ONE PROGRAMMER INTERROGATION. MOREOVER, TWO SEPARATE CODE 1003 WERE NOTED, ONE AFTER A SMALL POWER SPIKE AND THE OTHER A COUPLE DAY AFTER THE POWER SPIKE FROM TELEMETRY. FURTHERMORE, IT WAS DETERMINED THAT THIS FAULT APPEARS TO BE FALSE POSITIVE. THE VOLTAGE WAS FOLLOWING THE EXPECTED VOLTAGE BASED ON THE POWER AND THE LATEST FAULT CAN BE CLEARED AND NO FURTHER ACTIONS ARE REQUIRED. TS ALSO EXPLAINED THAT DEVICE WILL CONTINUE BEEPING UNTIL INTERROGATE WITH A PROGRAMMER. FURTHER DATA ANALYSIS WAS PERFORMED, AND RESULT SHOWED THAT THIS DEVICE EXHIBITED PREMATURE BATTERY DEPLETION (PBD). TS THEN RECOMMENDED DEVICE REPLACEMENT. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707706 ↗
• MalfunctionJan 30, 2024Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THAT THE HEALTHCARE PROFESSIONAL (HCP) REQUESTED REVIEW OF DEVICE DATA TO CONFIRM DEVICE OPERATION OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). UPON REVIEW, BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) NOTED THERE WAS OVERSENSING OF VENTRICULAR SIGNALS ON THE LEFT VENTRICULAR (LV) LEAD WHICH RESULTED IN PACING INHIBITION. TS DISCUSSED POSSIBLE PROGRAMMING OPTIONS PER PHYSICIAN DISCRETION. 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 18610748 ↗
• MalfunctionJan 11, 2024Over-Sensing; Pacing Problem; Off-Label Use; Over-Sensing; Pacing Problem; Off-Label Use

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED WITH CONCERNS ABOUT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITING PACING INHIBITION AND REQUESTED AN EVALUATION CONSULT OF THIS CRTD FROM TECHNICAL SERVICES (TS). THE HCP NOTED THAT THE PATIENT HAD PREVIOUSLY HAD A NON-BOSTON SCIENTIFIC DEVICE IMPLANTED CONCOMITANTLY WITH THIS CRTD DEVICE DUE TO DEVICE NEARING END OF SERVICE (EOS) AND THIS CRTD DEVICE WAS PROGRAMMED TO VENTRICULAR PACING ONLY. TS REVIEWED THE DATA PROVIDED AND NOTED THAT THE CRTD MAY HAVE OVERSENSED A BEAT WHICH LED TO THE CRTD DEVICE TO INHIBIT PACING. TS RECOMMENDED FOR DEVICE TO REPLACED. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499431 ↗
• InjuryJan 1, 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 18423297 ↗
• InjuryDec 4, 2023Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND OVERSENSING. THE PHYSICIAN OPTED TO SURGICALLY ABANDON IT, WHILE THE DEVICE WAS EXPLANTED. BOTH PRODUCTS WERE SUCCESFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18262027 ↗
• InjuryNov 20, 2023Signal Artifact/Noise; Over-Sensing; Device Sensing Problem; Signal Artifact/Noise; Over-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS BEING SEEN IN THE CLINIC FOR ELECTIVE REPLACEMENT INDICATOR (ERI). ADDITIONALLY, IT WAS NOTED THAT THE DEVICE ALSO EXHIBITED LOW SENSING AND NOISE ON THE RIGHT ATRIAL CHANNEL, THIS NOISE WAS BEING OVERSENSED. PATIENT UNDERWENT GENERATOR CHANGE AND REPORTEDLY, UPON OPENING THE POCKET A LARGE AMOUNT OF UNEXPECTED PUS WAS DISCOVERED. A REVISION WAS PERFORMED AND THE CRT-D ALONG WITH THE RIGHT VENTRICULAR (RV) LEAD, RIGHT ATRIAL (RA) LEAD AND LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 18172506 ↗
• MalfunctionNov 17, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) REVIEWED TROUBLESHOOTING OPTIONS. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166423 ↗
• MalfunctionOct 23, 2023Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM REVEALED OVERSENSED NOISE WITH PACING INHIBITION ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL. TECHNICAL SERVICES (TS) STATES THAT THE NOISE LOOKED LIKE ELECTROMAGNETIC INTERFERENCE (EMI), AS THE SIGNALS WERE TOO FAST FOR MYPOTENTIAL NOISE. THE PATIENT DOES NOT RECALL WHAT THEY WERE DOING AT THE TIME OF THE EPISODE, AND NO FURTHER EPISODES HAVE BEEN STORED. ALL LEAD MEASUREMENTS ARE WITHIN NORMAL LIMITS. TECHNICAL SERVICES (TS) REVIEWED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS CRT-D SYSTEM REMAINS IN SERVICE, AND WILL CONTINUE TO BE MONITORED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM STORED ANOTHER EPISODE WITH SIMILAR NOISE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL, AND ELECTROMAGNETIC INTERFERENCE (EMI) WAS SUSPECTED. AT THE TIME OF THE PREVIOUS EPISODE IN OCTOBER, THE PATIENT REPORTED DIZZINESS, FEELING SICK, VOMITING, AND DIARRHEA. THE PATIENT WAS SCHEDULED FOR A FOLLOW UP VISIT. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: Diarrhea; Dizziness; Malaise; No Clinical Signs, Symptoms or Conditions; Vomiting

  MAUDE report 17990357 ↗
• DeathOct 17, 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) SYSTEM EXHIBITED AN INFECTION. AS A RESULT, THE CRT-D DEVICE, THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS UNABLE TO BE EXTRACTED AND IT WILL BE REMOVED WHEN THE PATIENT UNDERGOES AN AORTIC VALVE REPLACEMENT. THE RV AND LV LEADS ARE NOT BOSTON SCIENTIFIC PRODUCTS. IN ADDITION, A NEW RV LEAD WAS TEMPORARILY IMPLANTED. IT WAS SUBSEQUENTLY REPORTED THAT THE PATIENT PASSED AWAY APPROXIMATELY EIGHT HOURS AFTER THE SURGICAL PROCEDURE DUE TO COMPLICATIONS. IT WAS INDICATED THAT THE EXTRACTED PRODUCTS WILL NOT BE RETURNED.

  Patient problems: Unspecified Infection

  MAUDE report 17950997 ↗

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-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, 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-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-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-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-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-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-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.