Protecta™ XT VR D314VRG (UDI 00613994678164)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994678164), received between Feb 8, 2018 and May 23, 2023 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Charge” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS). THE PATIENT AND PHYSICIAN ELECTED TO KEEP THE ICD IMPLANTED. THE DEVICE TRIGGERED AN ALERT FOR CHARGE CIRCUIT INACTIVE. ALERTS WERE PROGRAMMED OFF AND 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 16984074 ↗
• InjuryMar 2, 2023Failure to Charge; Electrical /Electronic Property Problem; Battery Problem; Failure to Charge; Electrical /Electronic Property Problem; Battery Problem

  IT WAS REPORTED THAT THE DEVICE HAD BEEN LEFT IMPLANTED PAST END OF SERVICE (EOS). HIGH VOLTAGE THERAPIES WERE PROGRAMMED OFF, BUT PACING IS STILL FUNCTIONING. THE DEVICE HAS TRIGGERED ALERT TONES FOR CHARGE CIRCUIT TIMEOUT AND CHARGE CIRCUIT INACTIVE. 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 16466941 ↗
• MalfunctionOct 8, 2021Battery Problem: High Impedance; Battery Problem: High Impedance

  THE DEVICE WAS REPLACED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599485 ↗
• MalfunctionMay 10, 2021Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BEGAN TONING FOR CHARGE CIRCUIT TIMEOUT. IT WAS ADDITIONALLY REPORTED THAT THE ICD HAD BEEN DEACTIVATED APPROXIMATELY THREE YEARS PREVIOUSLY WHEN A REPLACEMENT ICD HAD BEEN IMPLANTED BUT THE CHRONIC ONE WAS NOT REMOVED. THE CALLER WAS ABLE TO INTERROGATE MULTIPLE TIMES WHICH EVENTUALLY RESULTED IN SEEING THE OBSERVATION FOR "CHARGE CIRCUIT INACTIVE." THE CALLER THEN CHOSE THE "CLOSE" OPTION IN ORDER TO SILENCE THE ALERT AND PREVENT FUTURE CHARGING. THE ICD 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 11801369 ↗
• MalfunctionNov 20, 2020Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS AN EXCESSIVE 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 10876275 ↗
• MalfunctionNov 21, 2019Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED AN ALERT DUE TO CHARGE CIRCUIT TIMEOUT. THE DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) ROUGHLY TWO YEARS PRIOR AND THE PATIENT REFUSED EXPLANT OF THE DEVICE. 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 9355485 ↗
• InjuryOct 3, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CAUSED HIGH RIGHT VENTRICULAR (RV) THRESHOLDS. THE ICD 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 9154022 ↗
• MalfunctionDec 7, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PHYSICIAN INDICATED THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION AND HAD TRIGGERED RECOMMENDED REPLACEMENT TIME (RRT) EARLIER THAN EXPECTED. THE DEVICE CURRENTLY REMAINS IN USE AND A DEVICE CHANGEOUT WILL BE SCHEDULED FOR A FUTURE DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8141527 ↗
• MalfunctionAug 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE REMOTE TRANSMISSION HAS THE CORRECT DATE BUT THE TIME IS IN THE FUTURE. IT WAS EXPLAINED THAT THE REMOTE TRANSMISSION WILL ONLY DISPLAY THE TIME IT GETS FROM THE DEVICE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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 7768877 ↗
• InjuryApr 10, 2018Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION AND WAS UNABLE TO BE INTERROGATED. 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 7416459 ↗
• InjuryFeb 8, 2018Failure to Charge; Delayed Charge Time; Battery Problem; Failure to Charge; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THE PATIENT HEARD AUDIBLE TONES AND WENT TO THE EMERGENCY ROOM. IT WAS FOUND THAT THE DEVICE HAD A CHARGE CIRCUIT TIMEOUT OCCUR AND THAT THE CHARGE TIME WAS NOTED TO BE GREATER THAN THIRTY SECONDS. IT WAS ALSO NOTED THAT A WARNING THAT ATP (AN TI-TACHYCARDIA PACING) AND SHOCK THERAPIES WILL NOT BE DELIVERED: CHARGE CIRCUIT INACTIVE AND THAT THE DEVICE WAS AT END OF SERVICE (EOS) AND TO REPLACE IMMEDIATELY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OFTHIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7254503 ↗