Protecta VRRecalls & reported problems across all models

We found 2 models of Protecta VR by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 84 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2017 and May 19, 2026 — classified as 3 deaths, 60 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (14 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 VR problems

Protecta VR models

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

• Protecta™ VR D334VRG

  Implantable cardioverter defibrillator (non-CRT)
  2 deaths65 reports
• Protecta™ VR D334VRM

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death19 reports

Recent Protecta VR adverse event reports

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

• InjuryMay 19, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED AN INAPPROPRIATE SHOCK DUE TO THEIR LOW SODIUM COUNT. THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Shock from Patient Lead(s)

  MAUDE report 25225615 ↗
• InjuryMay 19, 2026Electromagnetic Interference

  IT WAS REPORTED BY THE PATIENT THAT CAUTERY WAS USED AT A DERMATOLOGIST APPOINTMENT AND A MAGNET WAS USED. DURING CAUTERY THE PATIENT WAS SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25225543 ↗
• MalfunctionMar 16, 2026Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ALERTS FOR CHARGE CIRCUIT INACTIVE, END OF SERVICE (EOS) CHARGE CIRCUIT TIMEOUT, AND LONG CHARGE TIME. 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 24607697 ↗
• MalfunctionMar 5, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED ALERT FOR END OF SERVICE (EOS). IT WAS ALSO REPORTED THAT APPROXIMATELY 30 DAYS LATER, THE ICD TRIGGERED AN ALERT FOR CHARGE CIRCUIT INACTIVE AND BEEPING EVERY 20 HOURS SINCE. GUIDANCE WAS PROVIDED ON CLEARING THE ALERTS. 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 24521162 ↗
• InjuryJan 29, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH HAD REACHED END OF SERVICE (EOS) A FEW YEARS PRIOR, EXHIBITED AN INACTIVE CHARGE CIRCUIT. 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 24207595 ↗
• DeathJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER AFTER THE PATIENT¿S DEATH WITH PAPERWORK INDICATING THE DEVICE HAD NOT BEEN FUNCTIONING WITHIN NORMAL TOLERANCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 22456710 ↗
• InjuryDec 26, 2024Failure 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) WAS ALERTING POST END OF SERVICE (EOS) STATUS. THE DEVICE HAD EXPERIENCED A CHARE CIRCUIT TIMEOUT, AND REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 21019208 ↗
• InjuryJun 12, 2024Inappropriate/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 SHOCKED THE PATIENT, THERAPY WAS INITIALLY WITHHELD BY THE DISCRIMINATOR. IT WAS SUSPECTED THAT THE RHYTHM WAS ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE, THEREFORE THE THERAPY WAS INAPPROPIATE. THE DEVICE 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 19522591 ↗
• InjuryMay 1, 2024Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND HAD A CHARGE CIRCUIT INACTIVE ,AND A CHARGE CIRCUIT TIMEOUT. THE PATIENT WAS HOSPITALIZED BUT OPTED TO LEAVE THE DEVICE IMPLANTED. 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 19221913 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THE PHYSICIAN WANTED TO REMOVE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). HOWEVER, THE PATIENT LEFT THE HOSPITAL, AGAINST MEDICAL ADVICE, AND NO INTERVENTION WAS DONE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19031390 ↗
• InjuryMar 29, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY DELIVERED SHOCKS AND ANTI-TACHYCARDIA PACING FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WHEN THE DEVICE MISCLASSIFIED EPISODES AS VENTRICULAR TACHYCARDIA (VT) AND FAST VENTRICULAR TACHYCARDIA (FVT). IT WAS NOTED THAT THE PATIENT FELL. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; Shock from Patient Lead(s)

  MAUDE report 19006975 ↗
• MalfunctionJan 29, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED BY THE PATIENT THAT THE REMOTE MONITOR AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD NO TELEMETRY AND A REMOTE MONITORING TRANSMISSION WAS UNABLE TO BE SENT. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL AND THE PATIENT WAS REFERRED TO THE CLINIC. THE MONITOR AND ICD 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 18596848 ↗
• InjuryNov 8, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED PREMATURE BATTERY DEPLETION. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS AND THE OUTPUTS HAD BEEN PROGRAMMED ACCORDINGLY. THE ICD WAS EXPLANTED AND REPLACED. THE RV 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 18095156 ↗
• MalfunctionSep 15, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED AN ALERT FOR CHARGE CIRCUIT INACTIVE. 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 17755122 ↗
• InjurySep 6, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

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

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17690670 ↗

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