Protecta™ XT DR D314DRMRecalls & reported problems

Summary

The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 00613994714572), received between Dec 9, 2016 and Apr 15, 2025 — classified as 8 deaths, 109 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (31 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 155 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR), EXTERNAL DEFIBRILLATION, AND ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) WERE PERFORMED FOR THE PATIENT'S VENTRICULAR FIBRILLATION (VF) AND PULSELESS ELECTRICAL ACTIVITY (PEA). IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS AND WAS UNABLE TO BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 21843902 ↗
• InjuryApr 3, 2025Adverse 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 AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21764699 ↗
• InjuryJan 10, 2025Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21128947 ↗
• InjuryJun 10, 2024Failure to Charge; Electrical /Electronic Property Problem; Pacing Problem; Delayed Charge Time; Device Sensing Problem; Failure to Charge; Electrical /Electronic Property Problem; Pacing Problem; Delayed Charge Time; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHEN THE DEVICE DETECTED THE EPISODE AS FAST VENTRICULAR TACHYCARDIA (FVT). IT WAS ALSO NOTED THAT CHARGE CIRCUIT TIMEOUT AND CHARGE CIRCUIT INACTIVE ALERTS WERE TRIGGERED AT END OF SERVICE (EOS). IT WAS ALSO NOTED THAT THE CHARGE TIME WAS LONGER THAN EXPECTED. 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 19503563 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD MALFUNCTIONED. THE LEAD WAS CAPPED AND A NEW RV LEAD WAS IMPLANTED. IN ADDITION, THE PATIENT EXPERIENCED PAIN AT THE DEVICE POCKET. A POCKET REVISION WAS PERFORMED WITH RELOCATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO A SUBPECTORAL POSITION DUE TO EROSION. IT WAS FURTHER REPORTED THAT THE ICD WAS LATER EXPLANTED AND REPLACED AFTER REACHING END-OF-LIFE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 19014231 ↗
• InjuryMar 25, 2024Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE REASON THE ICD WAS UNABLE TO BE INTERROGATED WAS THAT THE ICD IN QUESTION WAS EXPLANTED AND REPLACED SEVERAL YEARS PRIOR BY A COMPETITOR PRODUCT.

  Patient problems: Syncope/Fainting

  MAUDE report 18967871 ↗
• MalfunctionFeb 27, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ABNORMAL BATTERY DEPLETION. THE ICD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787546 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT PATIENT WAS HOSPITALIZED FOR THREE DAYS WITH AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED THREE DAYS POST DISCHARGE. IT WAS NOTED THAT THE ICD WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE INFECTION SOURCE WAS REQUESTED BUT WAS NOT PROVIDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18543056 ↗
• InjuryNov 20, 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 PRESENTED TO THE HOSPITAL FOR CARDIAC ARREST. REVIEW OF THE REMOTE TRANSMISSION SHOWED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN LACK OF DETECTION AND FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS. IN ADDITION, FAR FIELD R-WAVE (FFRW) OVERSENSING WAS NOTED ON A STORED ELECTROGRAMS (EGM) THAT POSSIBLY RESULTED IN DELAYED TERMINATION OF AN AT/AF EVENT. THERE WAS A DECREASE IN P-WAVE AMPLITUDE AND VARIATION IN MEASUREMENTS NOTED IN LEAD TRENDS. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) FOURTEEN MONTHS PRIOR. THE ICD WAS NOW AT END OF SERVICE (EOS) AND CHARGE CIRCUIT INACTIVE OCCURRED. ALERTS WERE TRIGGERED FOR CHARGE CIRCUIT TIMEOUT (CCT) AND FOR LONG CHARGE TIME GREATER THAN 16 SECONDS. THE ICD AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 18176142 ↗
• InjuryOct 5, 2023Adverse 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 AN INFECTION. NO FURTHER PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17880102 ↗
• MalfunctionSep 5, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT WHILE PREPARING FOR A ROUTINE DEVICE CHANGEOUT THE DEVICE WAS UNABLE TO BE INTERROGATED. IT WAS NOTED THAT THE DEVICE HAD BEEN AT END OF SERVICE (EOS) FOR A LONG PERIOD OF TIME. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686123 ↗
• InjuryApr 6, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS DISPLACED TO THE LOWER CHEST WALL. IT WAS NOTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AT THE DEVICE SITE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 16691765 ↗
• MalfunctionMar 6, 2023Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE PATIENT HAD ELECTED TO KEEP THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BEYOND RECOMMENDED REPLACEMENT TIME (RRT) AND HAD THE ALERTS TURNED OFF IN 2021. THE ICD IS NOW TONING AGAIN DUE TO TRIGGERING A CHARGE CIRCUIT TIMEOUT ALERT. IT WAS NOTED THAT THE PATIENT IS A DNR (DO NOT RESUSCITATE) PATIENT. THE ICD REMAINS IN SITU. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486008 ↗
• InjuryJan 18, 2023Inappropriate/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 DELIVERED A SHOCK. IT WAS SUSPECTED THAT THE RHYTHM WAS ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR), AND IS THEREFORE INAPPROPRIATE. IT WAS ALSO NOTED THAT THERE WAS RIGHT ATRIAL (RA) LEAD UNDERSENSING THAT DID NOT APPEAR TO AFFECT MODE SWITCH. THE DEVICE AND 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 16194205 ↗
• InjurySep 30, 2022Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  IT WAS FURTHER REPORTED BY THE PATIENT THAT. THEY HAD GOTTEN AN INFECTION DUE TO THE PLACEMENT OF THE ICD, AND THEY HAVE PERMANENT D AMAGE IN THEIR ARMPIT FROM THE ICD AND ARE UNABLE TO ¿LIFT [THEIR] ARE ABOVE [THEIR] BREAST. THE PATIENT ALSO NOTED THAT THE DEVICE HAS BEEN ALERTING EVERY FOUR HOURS. THIS IS POTENTIALLY INDICATIVE OF A RIGHT VENTRICULAR (RV) LEAD ISSUE. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15514087 ↗
• InjuryJul 21, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING SHOCKS. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE PATIENT HAD BEEN TREATED FOR EPISODES OF VENTRICULAR TACHYCARDIA (VT), BUT THE RHYTHM WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 15075080 ↗
• InjuryJun 1, 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 FOR CHARGE TIME GREATER THAN 30 SECONDS. 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 14565516 ↗
• MalfunctionMay 20, 2022Electrical /Electronic Property Problem; Delayed Charge Time; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A CHARGE CIRCUIT TIMEOUT ALERT. THE DEVICE HAD REACHED END OF SERVICE (EOS) AND THE PATIENT DOES NOT WANT TO HAVE THE DEVICE REMOVED. 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 14463020 ↗
• InjuryFeb 3, 2022Failure to Charge; Failure to Deliver Shock/Stimulation; Delayed Charge Time; Failure to Charge; Failure to Deliver Shock/Stimulation; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A CHARGE CIRCUIT TIMEOUT AND FAILED TO PROVIDE THERAPY FOR A VENTRICULAR TACHYCARDIA (VT) EPISODE. IT WAS NOTED ON AN INTERROGATION REPORT THAT THE ICD HAD TRIGGERED ITS RECOMMENDED REPLACEMENT TIME (RRT) ALERT APPROXIMATELY 15 MONTHS PREVIOUSLY. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 13442078 ↗
• MalfunctionSep 13, 2021Premature Discharge of Battery; Delayed Charge Time; Premature Discharge of Battery; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTED FOR EXCESSIVE CHARGE TIME AND END OF SERVICE (EOS) BATTERY STATUS. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. 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 12460760 ↗
• MalfunctionAug 10, 2021Battery Problem; Protective Measures Problem; Battery Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS AT END OF SERVICE (EOS) AND A CHARGE CIRCUIT TIMEOUT HAS OCCURRED ON THE DEVICE. THE DEVICE IS ALERTING. 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 12303145 ↗
• InjuryAug 3, 2021Delayed Charge Time; Protective Measures Problem; Delayed Charge Time; Protective Measures Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268404 ↗
• InjuryJun 10, 2021Premature Discharge of Battery; Failure to Charge; Delayed Charge Time; Premature Discharge of Battery; Failure to Charge; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A CHARGE CIRCUIT TIMEOUT AND TRIGGERED A LONG CHARGE TIME ALERT WHICH TRIGGERED END OF SERVICE (EOS) EARLIER THAN EXPECTED. THE PATIENT WAS PROVIDED A LIFEVEST AND EVENTUALLY THE DEVICE WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11974646 ↗
• InjuryApr 1, 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 EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11602771 ↗
• MalfunctionMar 18, 2021Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED VENTRICULAR FIBRILLATION (VF) AND DELIVERED ANTI-TACHYCARDIA PACING. IT WAS SUSPECTED THAT THE RHYTHM WAS ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE. 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 11516163 ↗