Protecta™ XT DR D314DRG (UDI 00613994677891)Recalls & reported problems

Summary

The FDA's MAUDE database contains 329 adverse event reports that list this exact device (DI 00613994677891), received between Dec 9, 2016 and Sep 15, 2025 — classified as 4 deaths, 222 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (61 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 25 most recent of 329 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT ABOUT SIX YEARS AGO WHILE AT THE DOCTOR OFFICE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY SHOCKED. THE DEVICE REMAINED IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23057306 ↗
• InjurySep 15, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT BY THE PATIENT THAT NOT TOO LONG AFTER IMPLANT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY SHOCKED THEM WHILE IN THE SHOWER. THE DEVICE REMAINED IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23056235 ↗
• InjuryJul 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ¿STOPPED WORKING.¿ THE ICD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22632253 ↗
• MalfunctionJul 19, 2024Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS) AND TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT. 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 19782499 ↗
• InjuryJul 8, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SUPERIOR VENA CAVA (SVC) COIL WAS SUSPECTED TO BE INAPPROPRIATELY PINED IN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AT ICD CHANGE OUT THE LEAD WAS CONNECTED APPROPRIATELY TO THE NEW DEVICE. THE ICD WAS EXPLANTED AND REPLACE, THE LEAD 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 19689679 ↗
• InjuryMay 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT BACK IN 2018 THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED BECAUSE IT MALFUNCTIONED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324857 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT LIKELY HAS AN INFECTION AND THAT THE PHYSICIAN WANTS TO "DELAY CHANGEOUT". THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED ON A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18692156 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A SUSPECTED INFECTION, THE PATIENT HAD CLEAR DRAINAGE FROM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANT SITE. THE PATIENT WAS HOSPITALIZED AND TREATED WITH ANTIBIOTICS. THE EVENT WAS CONSIDERED RESOLVED FORTY EIGHT HOURS AFTER ANTIBIOTIC TREATMENT. THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 18106844 ↗
• MalfunctionOct 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL (HCP), THAT THE PATIENT INDICATED THAT THEIR DEVICE WAS NOT WORKING. THE HCP WAS NOT ABLE TO PROVIDE FURTHER DETAILS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 17969408 ↗
• InjurySep 12, 2023Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT INTERACTED WITH EXTERNAL EQUIPMENT AND WAS ELECTROCUTED BY THE EQUIPMENT, PASSED OUT, AND MAY HAVE RECEIVED ANOTHER SHOCK FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO THE EXTERNAL ELECTROMAGNETIC INTERFERENCE (EMI) EXPOSURE. THE DEVICE REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR DEFIBRILLATOR IMPEDANCE OUT OF RANGE. THE LEAD SENSING WAS TEMPORARILY REPROGRAMMED FROM RV-TIP TO RV-COIL AND OVERSENSING WAS NOTED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Electric Shock; Shock from Patient Lead(s); Syncope/Fainting

  MAUDE report 17733878 ↗
• InjuryMay 31, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING A SHOCK. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE PATIENT HAD BEEN TREATED FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF) BUT THE RHYTHM WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 17031144 ↗
• InjuryMay 26, 2023Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS FOUND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS), HAD A CHARGE CIRCUIT TIMEOUT, AND A LONGER CHARGE TIME THAN EXPECTED. THE FAMILY WAS AWARE THAT THE DEVICE WAS REACHING END OF SERVICE HAD DETERMINED THAT THE DEVICE WOULD NOT BE REPLACED. THE DEVICE REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 17011906 ↗
• MalfunctionApr 17, 2023Failure to Interrogate; Battery Problem; Failure to Interrogate; Battery Problem

  IT WAS REPORTED BY THE CLINIC THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) COULD NOT BE INTERROGATED AND IT WAS ASSUMED THAT THE ICD BATTERY WAS COMPLETELY DEPLETED. 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 16758653 ↗
• MalfunctionMar 21, 2023Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTED FOR CHARGE CIRCUIT TIMEOUT OR CHARGE CIRCUIT INACTIVE. IN ADDITION, IT WAS NOTED THAT THE PHYSICIAN CHOSE TO LEAVE THE DEVICE IMPLANTED IN THE PATIENT AFTER REACHING END OF SERVICE (EOS). THE DEVICE WAS BEEPING ONCE A DAY AT RANDOM TIMES THROUGHOUT THE DAY, DESPITE ALL ALERTS BEING PROGRAMMED OFF. 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 16588166 ↗
• InjuryNov 1, 2022Failure to Charge; Failure to Deliver Shock/Stimulation; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Failure to Deliver Shock/Stimulation; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD END OF SERVICE (EOS) WHEN BATTERY VOLTAGE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI)/RECOMMENDED REPLACEMENT TIME (RRT). AN ALERT WAS TRIGGERED DUE TO CHARGE CIRCUIT TIMEOUT. IN ADDITION, VENTRICULAR FIBRILLATION (VF) EPISODES WERE NOT TREATED. ANTI-TACHYCARDIA PACING(ATP) AND SHOCK THERAPIES WERE NOT DELIVERED AS CHARGE CIRCUIT TIMEOUT WAS INACTIVE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Presyncope; Syncope/Fainting

  MAUDE report 15710659 ↗
• MalfunctionOct 18, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PASSED END OF SERVICE (EOS) AND TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT. IT WAS NOTED THAT ALL THERAPIES AND ALERTS WERE DEACTIVATED PRIOR TO CHARGE CIRCUIT TIMEOUT ALERT. 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 15626023 ↗
• InjuryOct 5, 2022Failure to Charge; Failure to Charge

  IT WAS FURTHER REPORTED THAT THE ALERT WAS CLEARED AND ALL THERAPIES WERE PROGRAMMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544210 ↗
• MalfunctionSep 19, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE DEVICE REACHED END OF SERVICE (EOS) AND TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT. 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 15446542 ↗
• MalfunctionSep 6, 2022Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE DEVICE REACHED END OF SERVICE (EOS) AND TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT. 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 15364510 ↗
• MalfunctionAug 4, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS), AND AN ALERT FOR CHARGE CIRCUIT TIMEOUT HAD BEEN TRIGGERED. IT WAS NOTED THAT THE PATIENT DOES NOT WANT THEIR ICD EXPLANTED, SO THE DEVICE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164812 ↗
• InjuryJul 20, 2022Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS) AND THE CHARGE CIRCUIT TIMEOUT ALERT TONE HAD TRIGGERED. IT WAS FURTHER REPORTED THAT RIGHT VENTRICULAR (RV) LEAD HAD FRACTURED. THE PATIENT OPTED TO HAVE THE DEVICE DISABLED AND LEAVE THE DEVICE AND RV LEAD IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070971 ↗
• MalfunctionJul 18, 2022Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT - CHARGE CIRCUIT INACTIVE.  IT WAS FURTHER REPORTED THAT THE ICD IS NOT CURRENTLY IN USE AND WAS LEFT IMPLANTED POST-END OF SERVICE (EOS).  THE DEVICE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15043098 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POCKET INFECTION WAS DISCOVERED DURING A PROCEDURE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPL ANTED AND REPLACED. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14834234 ↗
• MalfunctionJun 16, 2022Failure 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) REACHED END OF SERVICE (EOS) AND CHARGE CIRCUIT INACTIVE OCCURRED. IN ADDITION, ALERTS WERE TRIGGERED FOR CHARGE CIRCUIT TIMEOUT AND EXCESSIVE CHARGE TIME. 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 14712666 ↗
• MalfunctionJun 2, 2022Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS AT END OF SERVICE (EOS) AND HAD A CHARGE CIRCUIT TIMEOUT / CHARGE CIRCUIT INACTIVE. 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 14578318 ↗