PUNCTUA CRT-DRecalls & reported problems across all models

We found 2 models of PUNCTUA CRT-D by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Apr 19, 2017 and Feb 25, 2025 — classified as 23 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (13 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 PUNCTUA CRT-D problems

PUNCTUA CRT-D models

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

• PUNCTUA™ CRT-D N051

  Implantable pulse generator, pacemaker (non-CRT)
  26 reports
• PUNCTUA™ CRT-D N050

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

Recent PUNCTUA CRT-D adverse event reports

The 15 most recent reports across all models, 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 ↗

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