Protecta™ VR D334VRGRecalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00613994677846), received between Apr 6, 2017 and May 19, 2026 — classified as 2 deaths, 45 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (12 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, 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 65 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED AN INAPPROPRIATE SHOCK DUE TO THEIR LOW SODIUM COUNT. THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Shock from Patient Lead(s)

  MAUDE report 25225615 ↗
• InjuryMay 19, 2026Electromagnetic Interference

  IT WAS REPORTED BY THE PATIENT THAT CAUTERY WAS USED AT A DERMATOLOGIST APPOINTMENT AND A MAGNET WAS USED. DURING CAUTERY THE PATIENT WAS SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25225543 ↗
• MalfunctionMar 16, 2026Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ALERTS FOR CHARGE CIRCUIT INACTIVE, END OF SERVICE (EOS) CHARGE CIRCUIT TIMEOUT, AND LONG CHARGE TIME. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607697 ↗
• MalfunctionMar 5, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED ALERT FOR END OF SERVICE (EOS). IT WAS ALSO REPORTED THAT APPROXIMATELY 30 DAYS LATER, THE ICD TRIGGERED AN ALERT FOR CHARGE CIRCUIT INACTIVE AND BEEPING EVERY 20 HOURS SINCE. GUIDANCE WAS PROVIDED ON CLEARING THE ALERTS. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521162 ↗
• DeathJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER AFTER THE PATIENT¿S DEATH WITH PAPERWORK INDICATING THE DEVICE HAD NOT BEEN FUNCTIONING WITHIN NORMAL TOLERANCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 22456710 ↗
• InjuryDec 26, 2024Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALERTING POST END OF SERVICE (EOS) STATUS. THE DEVICE HAD EXPERIENCED A CHARE CIRCUIT TIMEOUT, AND REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 21019208 ↗
• InjuryJun 12, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED VENTRICULAR FIBRILLATION (VF) AND SHOCKED THE PATIENT, THERAPY WAS INITIALLY WITHHELD BY THE DISCRIMINATOR. IT WAS SUSPECTED THAT THE RHYTHM WAS ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE, THEREFORE THE THERAPY WAS INAPPROPIATE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19522591 ↗
• InjuryMay 1, 2024Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND HAD A CHARGE CIRCUIT INACTIVE ,AND A CHARGE CIRCUIT TIMEOUT. THE PATIENT WAS HOSPITALIZED BUT OPTED TO LEAVE THE DEVICE IMPLANTED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221913 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THE PHYSICIAN WANTED TO REMOVE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). HOWEVER, THE PATIENT LEFT THE HOSPITAL, AGAINST MEDICAL ADVICE, AND NO INTERVENTION WAS DONE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19031390 ↗
• InjuryMar 29, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY DELIVERED SHOCKS AND ANTI-TACHYCARDIA PACING FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WHEN THE DEVICE MISCLASSIFIED EPISODES AS VENTRICULAR TACHYCARDIA (VT) AND FAST VENTRICULAR TACHYCARDIA (FVT). IT WAS NOTED THAT THE PATIENT FELL. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; Shock from Patient Lead(s)

  MAUDE report 19006975 ↗
• MalfunctionJan 29, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED BY THE PATIENT THAT THE REMOTE MONITOR AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD NO TELEMETRY AND A REMOTE MONITORING TRANSMISSION WAS UNABLE TO BE SENT. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL AND THE PATIENT WAS REFERRED TO THE CLINIC. THE MONITOR AND ICD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596848 ↗
• MalfunctionSep 15, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED AN ALERT FOR CHARGE CIRCUIT INACTIVE. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755122 ↗
• InjurySep 6, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17690670 ↗
• InjuryJul 26, 2023Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  IT WAS FURTHER REPORTED THAT THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401812 ↗
• MalfunctionMar 28, 2023Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTION AND THERAPY WAS PROGRAMMED OFF ONE YEAR AFTER DEVICE IMPLANT AND LEFT IN USE. THE DEVICE DECLARED RECOMMENDED REPLACEMENT TIME (RRT) SEVERAL YEARS AGO AND STILL REMAINED IN USE. THE DEVICE RECENTLY ALERTED FOR CHARGE CIRCUIT TIMEOUT AND CHARGE CIRCUIT INACTIVE AND DECLARED END OF SERVICE (EOS). THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628360 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE PREVIOUSLY WAS SWELLING AT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SITE. THE POCKET WAS OPENED, AND A ¿LARGE SEMI-DENSE LAYER OF ORGANIZED HEMATOMA¿ WAS FOUND. EXTENSIVE POCKET DEBRIDEMENT WAS DONE TO REMOVE THE HEMATOMA. THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 15419677 ↗
• InjuryFeb 9, 2022Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR DETECTING A SUPRA VENTRICULAR TACHYCARDIA (SVT) ARRHYTHMIA AS A VENTRICULAR FIBRILLATION (VF) EPISODE. THE DEVICE HAD BEEN AT RECOMMENDED REPLACEMENT TIME (RRT) FOR OVER A YEAR AND HAS NOW DECLARED END OF SERVICE (EOS). THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 13499283 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A BACTERIAL INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13397800 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VEGETATION WAS REPORTED ON THE RIGHT VENTRICULAR (RV) LEAD. A PROCEDURE WAS PLANNED TO REMOVE THE IMPLANTABLE C ARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12341593 ↗
• MalfunctionMay 12, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A VENTRICULAR TACHYCARDIA (VT) EPISODE AS SUPRA VENTRICULAR TACHYCARDIA (SVT) AND WITHHELD THERAPY. AFTER A REVIEW BY QUALIFIED PERSONNEL, IT WAS NOTED THAT THE VT ZONE WAS PROGRAMMED TO MONITOR ONLY AND THERE WAS NO THERAPY PROGRAMMED ON FOR THIS TYPE OF EPISODE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812493 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXTRACTED DUE TO LEAD VEGETATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11414995 ↗
• InjuryJan 20, 2021Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT. IT WAS NOTED THAT THE ICD WAS AT END OF SERVICE (EOS). THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11203723 ↗
• InjuryJan 12, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE PATIENT REPORTED THEY THOUGHT THEIR BATTERY MAY HAVE DEPLETED MORE QUICKLY THAN EXPECTED BASED ON THEIR LAST IN PERSON CLINIC CHECK. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155833 ↗
• InjuryJan 5, 2021Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 11117433 ↗
• MalfunctionNov 12, 2020Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN ISSUE WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT MADE THE RIGHT VENTRICULAR (RV) PACING IMPEDANCE READING EQUAL ZERO. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10830259 ↗