PUNCTUA™ CRT-D N051Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00802526480928), received between Apr 19, 2017 and Feb 25, 2025 — classified as 21 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (13 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS BEEN PROGRAMMED OFF FOR THREE YEARS. SUBSEQUENTLY, THIS CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458175 ↗
• MalfunctionOct 18, 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 AN EPISODE OF INAPPROPRIATE SHOCK DUE TO NOISE AND OVERSENSING. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE WAS EXPLANTED NINE YEARS AFTER IMPLANT. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20488491 ↗
• InjurySep 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time; Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD TRIGGERED CODE 1007 DUE TO CAPACITOR CHARGE TIME EXCEEDING LIMITATIONS. THE CHARGE TIMES WERE FOUND TO BE GREATER THAN 45 SECONDS. IT WAS RECOMMENDED THAT THE PRODUCT BE EXPLANTED AND REPLACED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20208650 ↗
• InjuryOct 3, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A RED CALL DOCTOR ALERT VIA THE ASSOCIATED REMOTE COMMUNICATOR, INDICATIVE A DEVICE CONDITION REQUIRING URGENT ATTENTION. TECHNICAL SERVICES (TS) RECOMMENDED THE PATIENT CONTACT THEIR CLINIC FOR REVIEW. THIS DEVICE WAS SUBSEQUENTLY EXPLANTED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860747 ↗
• InjuryJun 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time; Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time

  IT WAS REPORTED THAT CODE 1007 HAD BEEN TRIGGERED FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INDICATIVE OF CHARGE TIME EXCEEDING LIMITATIONS. IT WAS NOTED THAT THE DEVICE REACHED BATTERY CAPACITY DEPLETED (BCD) APPROXIMATELY 8 MONTHS AGO. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090427 ↗
• InjuryApr 10, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WENT TO ELECTIVE REPLACEMENT INDICATOR (ERI) SO QUICKLY. THE BATTERY OF THIS CRT-D WAS AT SEVEN MONTHS LAST FEBRUARY AND NOW REACHED ERI. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IT LOOKS LIKE CHARGE TIME WAS GREATER THAN FIFTEEN SECONDS AND SO ERI WAS TRIPPED. TS OFFERED ADDITIONAL ANALYSIS, BUT THE FIELD REPRESENTATIVE DECLINED. TO DATE, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS DEVICE WAS EXPLANTED, AND A NEW DEVICE WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709308 ↗
• InjuryNov 2, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PREVIOUSLY SHOWED THREE AND A HALF YEARS REMAINING LONGEVITY. DURING THE RECENT CHECK THE DEVICE SHOWED NINE MONTHS LEFT. ANALYSIS SHOWED THAT A LOW VOLTAGE FAULT WAS NEVER DECLARED AND THE DEVICE WAS DEPLETING IN A MANNER CONSISTENT WITH THE LOW VOLTAGE CAPACITORS ADVISORY. THERE WERE NO OTHER SUSPICIOUS FAULTS OR RESETS STORED WITHIN DEVICE MEMORY. THE DEVICE HARDWARE WAS NOT DETECTING THE LOSS OF BATTERY ENERGY. BECAUSE OF THIS, THE BATTERY STATUS INDICATORS WERE NOT REFLECTING THE DEPLETION CONDITION AND WERE INACCURATE. THE DEVICE WAS MALFUNCTIONING. THE DEVICE SHOULD BE REPLACED AND RETURNED FOR DETAILED ANALYSIS. THIS CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12735730 ↗
• InjuryOct 17, 2021Adverse 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 12644269 ↗
• MalfunctionJul 13, 2021Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THERE WAS NOISE ON THE RIGHT VENTRICULAR (RV) LEAD THAT WAS SENSED AND RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING AND SHOCK THERAPY, ALONG WITH MULTIPLE NON-SUSTAINED VENTRICULAR EPISODES. THE RV PACE IMPEDANCE WAS ALSO GREATER THAN 2,500 OHMS. AT THIS TIME THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR AND RV LEAD (NON-BOSTON SCIENTIFIC PRODUCT) REMAIN IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 12164193 ↗
• InjuryApr 13, 2021Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Inaccurate Synchronization; Data Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Inaccurate Synchronization; Data Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR EXPERIENCED SUPRAVENTRICULAR TACHYCARDIA (SVT). THE DEVICE PROVIDED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND INAPPROPRIATE SHOCKS. THIS HAPPENED ON THREE SEPARATE OCCASIONS. TECHNICAL SERVICES (TS) NOTED THAT IN SOME OF THE EPISODES THE ATP LOOKED LIKE IT WAS PRO-ARRHYTHMIC, PUTTING THE PATIENT INTO VENTRICULAR TACHYCARDIA. TS DISCUSSED PROGRAMMING OPTIONS WITH THE HEALTH CARE PROFESSIONAL. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia; Electric Shock; Tachycardia

  MAUDE report 11660669 ↗
• InjuryOct 1, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTEDLY RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS WAS NOT PERFORMED FOR THIS DEVICE. THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS. THE RETURNED IMPLANTABLE DEVICE WAS ANALYZED AND A REVIEW OF THE DEVICE MEMORY CONFIRMED THAT A LOW VOLTAGE ALERT, CODE 1003, WAS RECORDED. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED, BUT STILL SUPPORTED FULL DEVICE FUNCTION. NO OTHER SUSPICIOUS FAULTS OR RESETS WERE NOTED.

  Patient problems: No Code Available

  MAUDE report 10618088 ↗
• InjuryJul 21, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. THIS DEVICE WAS EXPLANTED AND IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Code Available

  MAUDE report 10306133 ↗
• InjuryJul 6, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE EXHIBITED PREMATURE BATTERY DEPLETION CONSISTENT WITH THAT OF A FAULT CODE 1003. DATA ANALYSIS WAS COMPLETED AND DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10236818 ↗
• MalfunctionJul 1, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) DUE TO RECEIVING SHOCKS FROM THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE. REVIEW OF THE DEVICE DATA INDICATED THAT THE PATIENT RECEIVED DEVICE SHOCKS TWO (2) DAYS PREVIOUSLY, A DEVICE INTERROGATION WAS PERFORMED WITH A PROGRAMMER AND THE DEVICE COUNTERS WERE RESET. THE PATIENT THEN RECEIVED ADDITIONAL DEVICE SHOCKS AND ONCE AGAIN PRESENTED TO THE ER. THE HEALTHCARE PROVIDER (HCP) INDICATED THAT THE PATIENT RECEIVED FOUR (4) FAILED DEVICE SHOCKS. DEVICE THERAPY WAS NOT NOTED TO HAVE BEEN EXHAUSTED. THE CORRESPONDING STORED EPISODES IN WHICH THERAPY WAS PROVIDED EXHIBITED A NON-SUSTAINED ARRHYTHMIA. EVIDENCE SUGGESTS THAT THE DEVICE SHOCKS WERE PROVIDED DUE TO AN ATRIAL-DRIVEN ARRHYTHMIA. THE HCP INDICATED THAT THEY WILL BE INVESTIGATING THE ISSUE. THE DEVICE REMAINS IN-SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 10222094 ↗
• MalfunctionJan 23, 2020Premature Discharge of Battery; Device Displays Incorrect Message; Premature Discharge of Battery; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY AND IT WAS REPORTED THAT A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9624114 ↗
• InjuryJan 3, 2020Device Displays Incorrect Message; Noise, Audible; Device Displays Incorrect Message; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT REPORTED HEARING TONES FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). A REMOTE MONITORING INTERROGATION FOUND THAT THE DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9548140 ↗
• InjuryJan 3, 2020Premature Discharge of Battery; Device Displays Incorrect Message; Premature Discharge of Battery; Device Displays Incorrect Message

  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. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE. THIS REPORT WILL BE UPDATED, SHOULD ADDITIONAL INFORMATION BE RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9547716 ↗
• InjuryJun 20, 2019Premature Discharge of Battery; Device Displays Incorrect Message; Premature Discharge of Battery; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR AND RECORDED A CODE 1003 WHICH IS INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. THIS PRODUCT WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8717850 ↗
• InjuryMay 6, 2019Premature Discharge of Battery; Premature Discharge of Battery

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD SUDDEN DECREASE IN LONGEVITY. THIS CRT-D WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8584434 ↗
• InjuryMay 6, 2019Premature Discharge of Battery; Device Displays Incorrect Message; Premature Discharge of Battery; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. SURGICAL INTERVENTION HAS BEEN PERFORMED AS THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8581485 ↗
• MalfunctionFeb 8, 2019Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED, HOWEVER SHORTLY BEFORE THE PROCEDURE THE PATIENT PASSED WAY DUE TO OTHER UNRELATED NATURAL CAUSES. THE DEVICE WAS LATER RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 8322816 ↗
• InjuryFeb 7, 2019Premature Discharge of Battery; Premature Discharge of Battery

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SHOWED 3.5 YEARS REMAINING IN BATTERY LIFE BUT LAST YEAR IT SHOWED 6 YEARS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) NOTED THAT THE PROGRAMMED OUTPUTS WERE NOMINAL. TS NOTED THAT THE PATIENT WAS IN ATRIAL FIBRILLATION (AF) AND THERE WERE THOUSANDS OF ATRIAL TACHY RESPONSE (ATR)S OBSERVED. TS DISCUSSED THAT BECAUSE OF THE AF, THE ATRIAL SENSE AMPLIFIERS ARE ON ALL OF THE TIME AND COULD IMPACT LONGEVITY. FURTHERMORE, TS ALSO STATED THAT THERE HAVE BEEN SEVERAL YELLOW ALERT TRANSMISSIONS WHICH COULD ALSO IMPACT THE LONGEVITY. THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS RETURNED FOR ANALYSIS. DEVICE ANALYSIS DETERMINED THAT THE DEVICE FAILED LABELED LONGEVITY CALCULATION. THERE WERE NO OTHER SUSPICIOUS FAULTS OR RESETS NOTED. THE DAILY BATTERY VOLTAGE MEASUREMENTS DISPLAYED A PATTERN OF STEADY AND RAPID DISCHARGE.

  Patient problems: Atrial Fibrillation; No Code Available

  MAUDE report 8314557 ↗
• InjuryFeb 5, 2019Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED LOSS OF CAPTURE AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THE LEFT VENTRICULAR (LV) LEAD, MEASURING GREATER THAN 2000 OHMS. THE PATIENT DIDN'T EXPERIENCED ASYSTOLE. A FRACTURE WAS SUSPECTED DUE TO THE IMPEDANCES, HOWEVER, A FRACTURE WAS NOT VISUALIZED ON FLUOROSCOPY. THE LV LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8306182 ↗
• InjuryJan 22, 2019Premature Discharge of Battery; Device Displays Incorrect Message; Premature Discharge of Battery; Device Displays Incorrect Message

  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 SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8268134 ↗
• InjuryJan 15, 2019Premature Discharge of Battery; Device Displays Incorrect Message; Premature Discharge of Battery; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 WHICH IS INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE HAS NOT BEEN RETURNED AT THIS TIME. IF THE DEVICE IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8250119 ↗

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-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-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-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-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.