Protecta DRRecalls & reported problems across all models

We found 3 models of Protecta DR by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 142 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2013 and Jan 7, 2026 — classified as 5 deaths, 104 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (45 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 DR problems

Protecta DR models

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

• Protecta™ DR D334DRG

  Implantable cardioverter defibrillator (non-CRT)
  3 deaths98 reports
• Protecta™ DR D334DRM

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death34 reports
• Protecta™ DR D334DRG

  Implantable cardioverter defibrillator (non-CRT)
  1 death10 reports

Recent Protecta DR adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJun 8, 2023Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD TRIGGERED RECOMMENDED REPLACEMENT TIME (RRT) AND A CHARGE CIRCUIT TIMEOUT OCCURRED SEVERAL YEARS AGO AND HAS NOW ALERTED FOR CHARGE CIRCUIT INACTIVE. THE PHYSICIAN AND PATIENT ELECTED TO LEAVE THE DEVICE IMPLANTED AND IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086739 ↗
• MalfunctionFeb 2, 2023Failure 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 16282610 ↗
• 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 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls