Protecta™ DR D334DRG (UDI 00613994677860)Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00613994677860), received between Aug 10, 2013 and Jan 7, 2026 — classified as 3 deaths, 73 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (25 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 98 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT "THE BATTERY WENT BAD" IN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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 23993713 ↗
• MalfunctionAug 22, 2024Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS  UNABLE INTERROGATE AND THE DEVICE DOE NOT MAKE A TONE WHEN A MAGNET. 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 20029157 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT EXPERIENCED AN INFECTION. THE DEVICE WAS EXPLANTED AND REPLACED.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19844298 ↗
• InjuryFeb 6, 2024Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Battery Problem; Charging Problem; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Battery Problem; Charging Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS), AND TRIGGERED A CHARGE CIRCUIT TIMEOUT. THE DEVICE 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 18650176 ↗
• MalfunctionJan 15, 2024Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT¿S TRANSVENOUS DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE DECISION WAS MADE TO IMPLANT A SUBCUTANEOUS DEVICE. THE TRANSVENOUS DEVICE AND ALL ALERTS WERE PROGRAMMED OFF. OVER FOUR YEARS LATER, THE PATIENT CONTACTED THEIR PHYSICIANS OFFICE AS THEIR TRANSVENOUS DEVICE WAS TONING. THE PATIENT WAS BROUGHT INTO THE OFFICE AND AN INTERROGATION SHOWED THAT THE DEVICE HAD ALERTED FOR EXCESSIVE CHARGE TIME GREATER THAN 25 SECONDS. THIS IS A NON-PROGRAMMABLE ALERT AND WILL STILL OCCUR WITH ALL ALERTS PROGRAMMED TO OFF. 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 18510223 ↗
• MalfunctionSep 25, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED BY MULTIPLE DIFFERENT PROGRAMMERS. 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 17810698 ↗
• InjuryJun 30, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED FAST VENTRICULAR TACHYCARDIA (FVT) AND DELIVERED SEVERAL SHOCKS. IT WAS SUSPECTED THAT THE RHYTHM WAS ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR), THEREFORE THE SHOCKS WERE INAPPROPRIATE.  IT WAS ALSO NOTED THAT THERE WAS INTERMITTENT UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE ICD AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17238199 ↗
• InjuryNov 9, 2022Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/UNDEFINED SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL IMPEDANCE, AND IT WAS ADDITIONALLY NOTED THAT THE SVC IMPEDANCE HAD BEEN FLUCTUATING FOR MORE THAN A YEAR. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED "CHARGE CIRCUIT TIMEOUT". IT WAS NOTED THAT THE ICD HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) STATUS APPROXIMATELY 7 MONTHS PRIOR AND WAS NOW AT END OF SERVICE (EOS) STATUS. BOTH THE LEAD AND THE ICD WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759814 ↗
• MalfunctionOct 21, 2022Failure to Charge; Delayed Charge Time; Failure to Charge; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTED FOR A CHARGE CIRCUIT TIMEOUT WITH A CHARGE TIME EXCEEDING THE LIMIT. THE DEVICE WAS ELECTIVELY LEFT IN USE PAST 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 15655998 ↗
• InjurySep 26, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNRESPONSIVE TO INTERROGATION AND WAS UNABLE TO BE TURNED OFF. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15486418 ↗
• InjurySep 14, 2022Failure to Charge; Failure to Interrogate; Failure to Charge; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT HAD TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) NEARLY TWO YEARS PRIOR EXPERIENCED A CHARGE CIRCUIT TIMEOUT. ADDITIONALLY, IT WAS REPORTED THAT THE ICD COULD NOT BE INTERROGATED TO TURN OFF THERAPIES. 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 15419577 ↗
• InjurySep 13, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THERE WAS A CHARGE CIRCUIT INACTIVE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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 15412239 ↗
• MalfunctionAug 17, 2022Failure to Charge; Electrical /Electronic Property Problem; Battery Problem; Failure to Charge; Electrical /Electronic Property Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED ALERTS FOR NON-PROGRAMMABLE PARAMETERS AFTER BEING IN USE PAST END OF SERVICE (EOS). THE DEVICE HAS A CHARGE CIRCUIT TIMEOUT. THE DEVICE INTERROGATED A CHARGE CIRCUIT INACTIVE STATUS. THE PATIENT IS ON HOSPICE AND THE DEVICE WILL NOT BE REPLACED. 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 15242044 ↗
• DeathMar 10, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT WAS DECEASED. THE CALLER REPORTED THAT THE PARAMEDICS TOLD HER THAT THE "DEVICE DID NOT DELIVER A SHOCK TO HIS HEART WHEN IT SHOULD HAVE, WHEN HIS HEART STOPPED". THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 13725582 ↗
• InjuryJan 14, 2022Battery Problem; Communication or Transmission Problem; Reset Problem; Battery Problem; Communication or Transmission Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A FULL POWER ON RESET (POR) OCCUR, THE ICD WAS AT END OF SERVICE (EOS,) AND WIRELESS TELEMETRY WAS NO LONGER AVAILABLE. 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 13258978 ↗
• InjurySep 13, 2021Failure 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) ALERTED FOR CHARGE CIRCUIT TIMEOUT. IT WAS NOTED THAT THE ICD HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) STATUS OVER A YEAR PRIOR. IT WAS FURTHER REPORTED THAT THE ICD EXHIBITED PROLONGED CHARGE TIME AND HAD REACHED A CHARGE CIRCUIT INACTIVE STATUS. 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 12460128 ↗
• InjuryApr 22, 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) WAS EXPLANTED AND REPLACED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11711493 ↗
• MalfunctionApr 2, 2021Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A CHARGE CIRCUIT TIMEOUT. THE DEVICE WILL NOT BE REPLACED PER PATIENT REQUEST AND WILL REMAIN IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607935 ↗
• MalfunctionNov 20, 2020Battery Problem: High Impedance; Battery Problem: High Impedance

  IT WAS REPORTED THAT THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING REMOVED AND REPLACED FOR NORMAL DEPLETION. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING THE MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10877177 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV) LEAD, AND RIGHT ATRIAL (RA) LEAD WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10759233 ↗
• InjuryOct 13, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHEN THE ICD DETECTED AN ATRIAL ARRHYTHMIA WITH RVR (RAPID VENTRICULAR RESPONSE) AS A VENTRICULAR FIBRILLATION (VF) EPISODE. THE ICD REMAINS IN USE. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE RA LEAD 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 10671193 ↗
• MalfunctionOct 13, 2020Failure to Charge; Electrical /Electronic Property Problem; Reset Problem; Failure to Charge; Electrical /Electronic Property Problem; Reset Problem

  IT WAS REPORTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) APPROXIMATELY TWO YEARS AGO AND IS NOW ALARMING. IT IS SUSPECTED THAT AN ELECTRICAL RESET HAS OCCURRED AND/OR A CHARGE CIRCUIT TIMEOUT/CHARGE CIRCUITINACTIVE HAS OCCURRED. THE ICD REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10670225 ↗
• MalfunctionSep 21, 2020Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT HAD BOTH ATRIAL TACHYCARDIA (AT)/ ATRIAL FIBRILLATION (AF) AND NONSUSTAINED VT EPISODE AT APPROXIMATELY THE SAME TIME DUE TO WHAT APPEARS TO BE EMI. 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 10561210 ↗
• InjurySep 1, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE PROVIDED INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 10477077 ↗
• InjuryJul 21, 2020Adverse 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 SYSTEMIC INFECTION. A NEW SYSTEM WILL BE IMPLANTED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10302516 ↗