Protecta XT DRRecalls & reported problems across all models

We found 3 models of Protecta XT DR by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 494 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 15, 2025 — classified as 12 deaths, 339 injuries, 143 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (94 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Protecta XT DR problems

Protecta XT DR models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Protecta™ XT DR D314DRG

  Implantable cardioverter defibrillator (non-CRT)
  4 deaths329 reports
• Protecta™ XT DR D314DRM

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  8 deaths155 reports
• Protecta™ XT DR D314DRG

  Implantable cardioverter defibrillator (non-CRT)
  10 reports

Recent Protecta XT DR adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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