Protecta™ VR D334VRMRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00613994714626), received between Aug 9, 2017 and Jan 29, 2026 — classified as 1 death, 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Delayed Charge Time” (3 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO INFECTION. THE RIGHT VENTRICULAR (RV) LEAD WAS INACTIVATED AND REMAINS IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15107931 ↗
• InjuryApr 19, 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) TRIGGERED ALERTS FOR CHARGE CIRCUIT TIMEOUT AND CHARGE CIRCUIT INACTIVE, AND CHARGE TIME GREATER THAN 30 SECONDS. THE DEVICE LATER ALERTED FOR RECOMMENDED REPLACEMENT TIME (RRT), AND THEN END OF SERVICE (EOS). 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 14142437 ↗
• InjuryJan 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD ABNORMAL SYSTEM FUNCTION AND WAS REMOVED. A NEW ICD WAS IMPLANTED. THE PATIENT IS ENROLLED 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 13256840 ↗
• InjurySep 21, 2021Premature Discharge of Battery; Failure to Charge; Premature Discharge of Battery; Failure to Charge

  IT WAS REPORTED THAT AN ALERT WAS TRIGGERED DUE TO CHARGE CIRCUIT TIMEOUT. IT WAS ALSO INDICATED THAT THE BATTERY HAD DEPLETED RAPIDLY AND REACHED END OF SERVICE (EOS) UNEXPECTEDLY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 12505845 ↗
• InjuryJul 19, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGEOUT PROCEDURE THERE WERE SEVERAL UNSUCCESSFUL ATTEMPTS TO RETRACT THE SETSCREW WITH THE WRENCH AND REMOVE THE RIGHT VENTRICULAR (RV) LEAD FROM THE HEADER OF THE DEVICE. THE PHYSICIAN ATTEMPTED TO ENLARGE AREA OF HEADER AROUND THE SETSCREW WITH A SCALPEL BUT WAS STILL UNABLE TO REMOVE THE LEAD. IT WAS LATER DETERMINED, THAT THE SETSCREW MAY HAVE BEEN PULLED FROM THE DEVICE WHEN USING THE SCALPEL AND THE LEAD WAS STILL STUCK INSIDE THE HEADER. THE LEAD WAS FORCEFULLY TUGGED TO DISLODGE THE LEAD FROM THE HEADER AND IT WAS THOUGHT THAT THE ISSUE MAY NOT HAVE BEEN WITH THE SETSCREW BUT THE HEADER. THE RV LEAD WAS USED WITH THE NEW ICD. THE CHRONIC 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 12189248 ↗
• InjuryNov 24, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT HAD RECEIVED TWENTY INAPPROPRIATE SHOCKS, AND IT WAS SUSPECTED THAT THE IMPLANTABLE CARDIOVERTER DE FIBRILLATOR (ICD) WAS TREATING SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES. 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 10896726 ↗
• MalfunctionNov 20, 2020Battery Problem: High Impedance; Battery Problem: High Impedance

  IT WAS REPORTED THAT THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING REMOVED, AND REPLACED FOR NORMAL DEPLETION. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING THE MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10877262 ↗
• InjuryMar 25, 2020Adverse 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 REMOVED DUE TO AN INFECTION. THE ICD WAS REPROGRAMMED PRIOR TO REMOVAL. THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO HAVE VEGETATION ON THE LEAD. DURING LEAD EXTRACTION, THE PATIENT SUFFERED A TEAR OF THE SUPERIOR VENA CAVA (SVC)/INNOMINATE JUNCTION REQUIRING EMERGENT OPEN HEART SURGERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9876889 ↗
• InjuryNov 12, 2019Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE DEVICE BATTERY VOLTAGE WAS 2.63 V BUT THE DEVICE HAD NOT YET REACHED RECOMMENDED REPLACEMENT TIME (RRT). CHARGE TIME WAS NOTED TO BE 18.2 SECS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9309306 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8984417 ↗
• MalfunctionApr 29, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS HAVING TELEMETRY ISSUES AS THEY COULD NOT GET TELEMETRY WITH THE ICD DUE TO THE PATIENT¿S LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS ALSO NOTED THAT THE TELEMETRY ISSUE ARISES WHEN ATTEMPTING TO USE NEAR-FIELD TELEMETRY WITH ANY PROGRAMMER. IT WAS SUGGESTED TO SHIELD THE PATIENT¿S CHEST WITH METAL PAN TO HELP BLOCK FIELDS GENERATED BY THE LVAD. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8561289 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED ANTIBIOTICS.

  Patient problems: Erosion; Swelling; Swelling/ Edema; Ulcer; Ulceration; Unspecified Infection; Wound Dehiscence

  MAUDE report 8262953 ↗
• MalfunctionNov 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS BROKEN AND NEEDS TO BE REPLACED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8095620 ↗
• DeathOct 18, 2018Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF DEATH WAS LISTED AS CARDIAC ARREST DUE TO PULSE-LESS ELECTRICAL ACTIVITY.

  Patient problems: Death

  MAUDE report 7980573 ↗
• InjuryJul 30, 2018Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO PREMATURE BATTERY DEPLETION. THE BATTERY LONGEVITY WAS LESS THAN EXPECTED. 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 Known Impact Or Consequence To Patient

  MAUDE report 7733936 ↗
• InjuryMay 1, 2018Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD TRIGGERED ALERTS FOR CHARGE CIRCUIT TIMEOUT, CHARGE CIRCUIT INACTIVE, AND LONG CHARGE TIME PRIOR TO BATTERY DEPLETION. THE DEVICE WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7478319 ↗
• InjuryAug 9, 2017Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing

  IT WAS REPORTED THE PATIENT RECEIVED A SHOCK AND THE DEVICE ¿READ¿ ANTI-TACHYCARDIA PACING AND DELIVERED THERAPY. THE PATIENT WAS HOSPITALIZED, TREATED WITH MEDICATION, AND RELEASED THE FOLLOWING DAY. APPROXIMATELY FOUR MONTHS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING FIFTEEN INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE PATIENT WAS HOSPITALIZED, TREATED WITH MEDICATION AND RE-PROGRAMMING OF THE DEVICE WAS PERFORMED. THE PATIENT WAS DISCHARGED AND THE EVENT WAS DEEMED RESOLVED. THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 6782220 ↗