Protecta™ DR D334DRG (UDI 00613994678157)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994678157), received between Feb 9, 2017 and Apr 8, 2022 — classified as 1 death, 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2022Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALERTING FOR A CHARGE-CIRCUIT TIMEOUT AND CHARGE-CIRCUIT INACTIVE, THOUGH IT WAS NOTED THAT IT WAS PAST END OF SERVICE (EOS) AND ALL ALERTS WERE PROGRAMMED OFF. 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 14055347 ↗
• InjuryAug 2, 2019Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A CHARGE CIRCUIT TIMEOUT AFTER DECLARING RECOMMENDED REPLACEMENT TIME (RRT). THE PATIENT ELECTED TO KEEP THE DEVICE INTACT AFTER THE RRT AND PROGRAMMED THERAPIES ¿OFF¿. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8854219 ↗
• MalfunctionJul 11, 2019Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THERE WAS AN AUDIBLE ALERT FROM THE DEVICE DUE TO THE PATIENT BEING TOO CLOSE TO A MAGNET. FOLLOW UP CONCLUDED NO INTERVENTION WAS PERFORMED AND THE PATIENT IS NOW AWARE TO BE COGNIZANT WHEN AROUND MAGNETS AS A TONE WILL BE DELIVERED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8782240 ↗
• InjuryJun 23, 2019Battery Problem; Inappropriate or Unexpected Reset; Battery Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS AT END OF SERVICE (EOS) AND EXPERIENCED A POWER ON RESET (POR) RESULTING IN LOST TRENDS/DATA. ALL DATA WAS CLEARED FROM THE DEVICE UPON INTERROGATION DUE TO ELECTRICAL RESET. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8725537 ↗
• InjuryFeb 4, 2019Delayed Charge Time; Battery Problem; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND THEN HAD AN EXCESSIVE CHARGE TIME ALERT WITH A CHARGE TIME OF GREATER THAN 16 SECONDS. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8302699 ↗
• InjuryNov 1, 2018Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED EXCESSIVE CHARGE TIME AND WENT STRAIGHT TO END OF SERVICE (EOS). THE DEVICE IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8028976 ↗
• InjuryApr 25, 2018Premature Discharge of Battery; Delayed Charge Time; Premature Discharge of Battery; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PREMATURELY REACHED END OF SERVICE (EOS) DUE TO EXCESSIVE CHARGE TIME. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7460107 ↗
• InjuryFeb 8, 2018Premature Discharge of Battery; Premature Discharge of Battery

  THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7254953 ↗
• DeathApr 20, 2017Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THE PATIENT IS DECEASED. THE DECEDENT¿S SPOUSE STATED THE PATIENT HAD DIFFICULTY BREATHING DURING THE AMBULANCE RIDE, THE PATIENT HAD A CARDIAC ARREST, AND THE DEVICE NEVER SHOCKED. THE PATIENT WENT INTO A COMA. THE SPOUSE STATED A PHYSICIAN SAID, ¿INTERROGATION OF THE DEVICE FOUND IT WAS SET TOO HIGH.¿ A REQUEST FOR ADDITIONAL INFORMATION WAS MADE, BUT WAS NOT AVAILABLE.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 6507795 ↗
• MalfunctionFeb 9, 2017Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN ANTICIPATED. THE DEVICE CURRENTLY REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6318115 ↗