Protecta XT CRT-DRecalls & reported problems across all models

We found 3 models of Protecta XT CRT-D by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 286 adverse event reports in the FDA's MAUDE database, received between Feb 25, 2013 and Feb 7, 2024 — classified as 7 deaths, 233 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (128 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 CRT-D problems

Protecta XT CRT-D models

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

• Protecta™ XT CRT-D D314TRG

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  6 deaths185 reports
• Protecta™ XT CRT-D D314TRM

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death99 reports
• Protecta™ XT CRT-D D314TRG

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 reports

Recent Protecta XT CRT-D adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) COULD NOT BE INTERROGATED. A DONUT MAGNET WAS PLACED OVER THE DEVICE AND THERE WERE NO TONES. THE CRT-D 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 18660728 ↗
• MalfunctionJan 11, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO BE INTERROGATED AND IT WAS SUSPECTED THAT THE DEVICE WAS AT END OF SERVICE (EOS). THE CRT-D 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 18494267 ↗
• InjuryAug 18, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEIR PREVIOUS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ONLY LASTED A FEW YEARS. 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 17573918 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO AN INFECTION AND WAS REPLACED WITH A LEADLESS PACEMAKER. IT WAS NOTED THAT THE PATIENT HAD LOW BLOOD PRESSURE, AND A BLOOD TRANSFUSION WAS REQUIRED DUE TO UNKNOWN COMPLICATIONS. IT WAS ADDITIONALLY REPORTED THAT DURING THE IMPLANT OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WHEN THE PHYSICIAN ATTEMPTED TO CROSS THE TRICUSPID VALVE, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF) AND REQUIRED EXTERNAL DEFIBRILLATION TO BREAK THE ARRHYTHMIA. FOLLOWING THE EXTERNAL DEFIBRILLATION WHEN THE LEADLESS IPG WAS POSITIONED IN THE PATIENT, THE MOBILE PROGRAMMER LOST TELEMETRY WITH THE DEVICE AND 'FROZE' DURING IMPEDANCE AND R-WAVE TESTING. THE LEADLESS IPG WAS SUCCESSFULLY CUT FROM THE TETHER AND REMAINS IMPLANTED, AND THE MOBILE PROGRAMMER REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Unspecified Infection

  MAUDE report 17142397 ↗
• MalfunctionMay 11, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE CLINICAL WAS TRYING TO DO A MANUAL TRANSMISSION, HOWEVER, THE REMOTE MONITOR HAD NO TELEMETRY WITH THE DEVICE. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE REMOTE MONITOR AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911233 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S RELATIVE THAT THE PATIENT WENT TO THE HOSPITAL DUE TO A BRADYCARDIA EPISODE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 16506112 ↗
• InjuryAug 15, 2022Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT STATED THAT THEIR PREVIOUS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE WAS EXPLANTED BECAUSE IT HAD A "PROBLEM." 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 15227698 ↗
• InjuryJul 7, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION. THE CRT-D WAS REPLACED WITH A COMPETITOR DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14944896 ↗
• MalfunctionFeb 2, 2022Failure to Charge; Failure to Interrogate; Failure to Charge; Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS AT END OF SERVICE (EOS) AND EXPERIENCED A CHARGE CIRCUIT TIMEOUT ALERT. THE CRT-D REMAINS IN THE PATIENT FOLLOWING A HEART TRANSPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13425396 ↗
• MalfunctionOct 6, 2021Pacing Problem; Communication or Transmission Problem; Pacing Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM ESTABLISHING TELEMETRY WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). WHEN TELEMETRY WAS FINALLY ABLE TO BE ESTABLISHED, IT SHOWED NO SIGNS OF PACING. THE CRT-D 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 12584174 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED DUE TO CELLULITIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cellulitis

  MAUDE report 12374433 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OPEN AND INFECTED DEVICE IMPLANT SITE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 12371034 ↗
• MalfunctionAug 12, 2021Failure 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 DECISION WAS MADE TO NOT REPLACE THE DEVICE AS THE PATIENT WENT TO HOSPICE CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313712 ↗
• InjuryJun 2, 2021Failure to Charge; Electrical /Electronic Property Problem; Battery Problem; Failure to Charge; Electrical /Electronic Property Problem; Battery Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD AN ALERT FOR A CHARGE CIRCUIT TIMEOUT. IT WAS NOTED THAT THE DEVICE TRIGGERED RECOMMENDED REPLACEMENT TIME (RRT) BACK IN 2018. 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 11921606 ↗
• InjuryJun 2, 2021Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT AN ALERT OCCURRED DUE TO A CHARGE CIRCUIT TIMEOUT ON A DEVICE THAT WAS PREVIOUSLY PROGRAMMED OFF PER PATIENT'S REQUEST. THE DEVICE WAS REPROGRAMMED AND THE CHARGE CIRCUIT WAS INACTIVATED. THE DEVICE REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921009 ↗

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