Protecta™ XT CRT-D D314TRG (UDI 00613994677884)Recalls & reported problems

Summary

The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 00613994677884), received between Feb 25, 2013 and Jan 11, 2024 — classified as 6 deaths, 143 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (69 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 185 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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; 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 ↗
• MalfunctionApr 30, 2021Charging Problem; Protective Measures Problem; Charging Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A CHARGE CIRCUIT INACTIVE ALERT. THE PATIENT DID NOT WANT TO HAVE THE DEVICE SYSTEM EXPLANTED AND AN INQUIRY WAS MADE AS TO HOW THE ALERTS COULD BE TURNED OFF. 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 11757453 ↗
• MalfunctionApr 28, 2021Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WHICH WAS PROGRAMMED TO A NON-PACING MODE AND LEFT IN THE HEART TRANSPLANT PATIENT EIGHT YEARS PRIOR, HAD EXHIBITED A CHARGE CIRCUIT TIMEOUT AFTER REACHING END OF SERVICE. 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 11739190 ↗
• InjuryApr 13, 2021Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) COULD NOT BE INTERROGATED DUE TO NORMAL BATTERY DEPLETION. AT THE TIME OF ICD EXPLANT AND REPLACEMENT A RIGHT VENTRICULAR (RV) LEAD FRACTURE WITH UNDEFINED/HIGH PACING IMPEDANCE WAS FOUND. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656567 ↗
• InjuryJan 11, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING A DEVICE GENERATOR CHANGE PROCEDURE FOR SUSPECTED PREMATURE BATTERY DEPLETION, WHEN OPENING THE POCKET A LEFT VENTRICULAR (LV) LEAD INSULATION TEAR OCCURRED. THE LV LEAD WAS "REPAIRED" WITH A SUTURE SLEEVE AND WAS KEPT AS THE ACTIVE LV LEAD. APPROXIMATELY THREE YEARS LATER, THE LV LEAD EXHIBITED LOW IMPEDANCE AND HIGH THRESHOLD. A PROCEDURE WAS SCHEDULED TO ATTEMPT ADDITIONAL LEAD PLACEMENT. DURING THE PROCEDURE IT WAS NOTED VIA ANGIOGRAM THAT AN OBSTRUCTION OF THE OSTIUM OF THE SINUS WAS PRESENT LIKELY FROM A SLIP-LIKE APPEARANCE AS THE RIGHT ATRIUM IS MARKEDLY DILATED. AS SUCH, MULTIPLE ATTEMPTS TO ACCESS THE CORONARY SINUS WERE UNSUCCESSFUL AND THE PROCEDURE WAS ABANDONED. THE PHYSICIAN THEN FOCUSED ON APPROACH TO THE LV EPICARDIAL LEAD. IT WAS NOTED THAT THE SUTURE SLEEVE AROUND THE AREA OF THE LV EPICARDIAL LEAD WAS DAMAGED, AND WAS REMOVED. THE SITE WAS THEN COVERED WITH SEALANT, THE CAP WAS CUT AROUND THE DAMAGED AREA AND THE AREA WAS SEALED OFF WITH SEVERAL SUTURES. THE LV EPICARDIAL LEAD WAS TESTED AND SHOWED IMPROVED AND ACCEPTABLE LEAD IMPEDANCE VALUES. THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146788 ↗
• InjuryDec 5, 2020Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC AND REPORTED THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD BEEN BEEPING FOR THREE MONTHS. THE DEVICE WAS INTERROGATED AND A CHARGE CIRCUIT TIMEOUT/CHARGE CIRCUIT INACTIVE WAS OBSERVED. IT WAS ALSO NOTED THAT THE DEVICE HAD REACHED RRT OVER TWO YEARS AGO. THE DEVICE WAS RE-INTERROGATED TO KEEP THE CAPACITORS FROM RECHARGING. THE PATIENT IS NOW PLANNING ON HAVING THE DEVICE 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 10950452 ↗
• MalfunctionNov 24, 2020Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES WERE POTENTIALLY THOUGHT TO BE ELECTROMAGNETIC INTERFERENCE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 10896383 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION OCCURRED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10872894 ↗
• MalfunctionNov 19, 2020Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ALERTED FOR CHARGE CIRCUIT TIME OUT AT 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 10868830 ↗
• InjuryNov 19, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INFECTION OCCURRED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10865829 ↗
• MalfunctionNov 3, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD REACHED THE RECOMMENDED REPLACEMENT TIME (RRT) SEVERAL YEARS AGO AND HAD NOW ALERTED DUE TO AN INACTIVE CHARGE CIRCUIT. REPROGRAMMING OF THE ALERT WAS DISCUSSED. THE DEVICE REMAINS IN THE PATIENT WITH NO PLANS FOR REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10780642 ↗
• InjuryOct 15, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE SHOCK WAS FOR ATRIAL TACHYCARDIA WITH RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR FIBRILLATION (VF).

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 10684016 ↗
• MalfunctionSep 30, 2020Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WHICH HAD PREVIOUSLY REACHED END OF SERVICE (EOS) AND WAS PROGRAMMED TO ALL THERAPIES AND ALERTS OFF, WAS ALERTING FOR CHARGE TIMEOUT. THE DEVICE REMAINS IN THE PATIENT WITH ALL THERAPIES PROGRAMMED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10609867 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10553743 ↗
• InjuryAug 6, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD NOT BEEN WORKING PROPERLY AND THAT THE BATTERY HAD ALREADY BECOME WEAK. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10372295 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RIGHT ATRIAL (RA) LEAD WAS RETURNED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP REVEALED THE ENTIRE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE SYSTEM WAS REPLACED APPROXIMATELY TWO MONTHS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10066380 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION OCCURRED. IT WAS FURTHER REPORTED THERE WAS REDNESS AND SWELLING AT THE DEVICE SITE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Swelling; Unspecified Infection

  MAUDE report 10043380 ↗