Protecta™ XT CRT-D D314TRMRecalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00613994714589), received between Aug 9, 2016 and Feb 7, 2024 — classified as 1 death, 89 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (59 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 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) COULD NOT BE INTERROGATED. A DONUT MAGNET WAS PLACED OVER THE DEVICE AND THERE WERE NO TONES. 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 18660728 ↗
• InjuryJun 16, 2023Adverse 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 REMOVED DUE TO AN INFECTION AND WAS REPLACED WITH A LEADLESS PACEMAKER. IT WAS NOTED THAT THE PATIENT HAD LOW BLOOD PRESSURE, AND A BLOOD TRANSFUSION WAS REQUIRED DUE TO UNKNOWN COMPLICATIONS. IT WAS ADDITIONALLY REPORTED THAT DURING THE IMPLANT OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WHEN THE PHYSICIAN ATTEMPTED TO CROSS THE TRICUSPID VALVE, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF) AND REQUIRED EXTERNAL DEFIBRILLATION TO BREAK THE ARRHYTHMIA. FOLLOWING THE EXTERNAL DEFIBRILLATION WHEN THE LEADLESS IPG WAS POSITIONED IN THE PATIENT, THE MOBILE PROGRAMMER LOST TELEMETRY WITH THE DEVICE AND 'FROZE' DURING IMPEDANCE AND R-WAVE TESTING. THE LEADLESS IPG WAS SUCCESSFULLY CUT FROM THE TETHER AND REMAINS IMPLANTED, AND THE MOBILE PROGRAMMER REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Unspecified Infection

  MAUDE report 17142397 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S RELATIVE THAT THE PATIENT WENT TO THE HOSPITAL DUE TO A BRADYCARDIA EPISODE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 16506112 ↗
• InjuryJul 7, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION. THE CRT-D WAS REPLACED WITH A COMPETITOR DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14944896 ↗
• InjuryJun 2, 2021Failure to Charge; Electrical /Electronic Property Problem; Battery Problem; Failure to Charge; Electrical /Electronic Property Problem; Battery Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD AN ALERT FOR A CHARGE CIRCUIT TIMEOUT. IT WAS NOTED THAT THE DEVICE TRIGGERED RECOMMENDED REPLACEMENT TIME (RRT) BACK IN 2018. 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 11921606 ↗
• InjuryOct 16, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION AND THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). 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 10691980 ↗
• MalfunctionJan 28, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR CHANGED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A SETSCREW ISSUE, WHERE THE LEAD WAS STUCK IN THE HEADER AND THE GROMMET AND SETSCREW HAD TO BE REMOVED IN ORDER TO GET THE LEAD OUT OF THE HEADER. THE CRT-D 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 9636565 ↗
• InjuryJan 14, 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 DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9588914 ↗
• InjuryDec 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT FELL DUE TO SYNCOPE AND WAS FOUND IN A HYPOTHERMIC STATE. THE PATIENT WAS ADMITTED TO AN ORTHOPEDIC FLOOR FOR THEIR INJURIES. THERE WAS SUSPECTED LOSS OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FUNCTION RELATED TO THE DEVICE HAVING REACHED END OF SERVICE (EOS). NO ARRHYTHMIC EPISODES HAD BEEN RECORDED AND NO HIGH VOLTAGE THERAPIES HAD BEEN DELIVERED AND CURRENT DEVICE MEASUREMENTS APPEARED TO BE WITHIN NORMAL LIMITS. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; Hypothermia; Syncope

  MAUDE report 9481055 ↗
• MalfunctionAug 23, 2019Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT WHEN ATTEMPTING TO INTERROGATE THE PACEMAKER, THE CLINICIAN WAS UNABLE TO GET THE PATIENT CONNECTOR TO RECOGNIZE THE DEVICE. THE CLINICIAN WAS CONTACTED AND IT WAS NOTED A PROGRAMMER WOULD BE ATTEMPTED TO ESTABLISH TELEMETRY WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). AT THIS TIME, TELEMETRY WITH THE DEVICE HAS NOT BEEN ESTABLISHED. FURTHER INFORMATION HAS BEEN REQUESTED. THE DEVICE AND PATIENT CONNECTOR REMAIN 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 8927881 ↗
• InjuryMay 6, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFTING (CABG) AND PATIENT¿S MEDICATION WAS DECREASED AT THAT TIME. SUBSEQUENTLY THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE PATIENT WAS HOSPITALIZED AS RESULT. THE DEVICE WAS REPROGRAMMED. THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 8583087 ↗
• InjuryApr 4, 2019Adverse 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 REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8481272 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE INCISION SITE WAS REDDENED AND SWOLLEN. THE PATIENT HAD A SUPERFICIAL INCISION SITE INFECTION. THE PATIENT WAS HOSPITALIZED AND TREATED WITH IV ANTIBIOTICS. THE INFECTION HAS NOT RESOSLVED AND WILL CONTINUE ON ANTIBIOTICS FOR 6 WEEKS. FURTHER ACTIONS/TREATMENTS ARE PLANNED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 2016-11-17: ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DISCHARGED HOME ON ORAL ANTIBIOTICS AND THE INFECTION RESOLVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 2019-03-18: THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY.

  Patient problems: Unspecified Infection

  MAUDE report 8429018 ↗
• InjuryMar 7, 2019Failure to Charge; Delayed Charge Time; Failure to Charge; Delayed Charge Time

  IT WAS REPORTED THAT THERE WAS AN ALERT ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR A CHARGE CIRCUIT TIMEOUT. AN INTERROGATION REPORT SHOWED THE DEVICE WAS AT END OF SERVICE (EOS) ONE MONTH PRIOR TO THIS. 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 8400812 ↗
• InjuryMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION OCCURRED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8392529 ↗
• InjuryFeb 8, 2019Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS BEEPING FOR NO APPARENT REASON. IT WAS NOTED THAT NO KNOWN ALERTS WERE TRIGGERED. 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 8322928 ↗
• InjuryJan 25, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE BATTERY DEPLETION. 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 8279222 ↗
• InjuryNov 30, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE REACHED POSSIBLE PREMATURE BATTERY DEPLETION. 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 8121266 ↗
• InjuryNov 5, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PHYSICIAN WAS CONCERNED THAT THE DEVICE WOULD NOT ACHIEVE 3 MONTHS' LONGEVITY FROM RECOMMENDED REPLACEMENT TIME (RRT) UNTIL END OF SERVICE (EOS). THE DEVICE WAS EXPLANTED AND REPLACED WHEN IT REACHED RRT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8037997 ↗
• InjuryOct 8, 2018Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING SURGERY AND RECEIVED AN INAPPROPRIATE SHOCK DUE TO ELECTROCAUTERY. AN IN-CLINIC CHECK NOTED A LEAD INTEGRITY ALERT OCCURRED DURING THE SURGERY FOR HIGH RATE NON-SUSTAINED EPISODES, NOISE AND SHORT VENTRICLE-VENTRICLE INTERVALS. THIS WAS PRESUMED DUE TO ELECTROCAUTERY; A MAGNET HAD BEEN PLACED ON THE DEVICE DURING THE SURGERY. THE DEVICE WAS CHECKED AND NO REPROGRAMMING WAS REQUIRED. THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 7945085 ↗
• MalfunctionAug 17, 2018Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. A LONGEVITY ESTIMATE APPROXIMATELY 3 YEARS AGO SHOWED TEN TO THIRTEEN MONTHS OF REMAINING LONGEVITY AT THAT TIME. IT WAS RECOMMENDED THAT THE DEVICE 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 7793982 ↗
• InjuryAug 16, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING DEVICE ROUTINE CHANGE OUT, THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING LEAD FROM DEVICE HEADER. IT WAS NOTED THERE WAS SOME TISSUE AND WAS FLUSHED OUT TO LOOSEN THE TISSUE. THEN PHYSICIAN PUSHED AND PULLED MULTIPLE TIMES TO FINALLY DISENGAGE LEAD FROM HEADER. 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 7790853 ↗
• MalfunctionAug 8, 2018Incorrect Measurement; Under-Sensing; Incorrect Measurement

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INTERROGATED AN ELECTROCARDIOGRAM (EGM) THAT HAD SHIFTED INTERVALS CAUSING WHAT APPEARS TO BE UNDERSENSING. 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 7763092 ↗
• InjuryAug 8, 2018Mechanical Problem; Difficult to Remove; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). DURING PROCEDURE TO REMOVE THE DEVICE, THE DOCTOR WAS UNABLE TO ENGAGE THE WRENCH IN THE SET SCREW TO LOOSEN AND REMOVE RIGHT VENTRICULAR (RV) LEAD. MULTIPLE TECHNIQUES TRIED TO ENGAGE THE SET SCREW BUT WAS UNSUCCESSFUL, SILICONE GROMMET WAS REMOVED TO VISUALIZE SET SCREW. SET SCREW FELL OUT OF THE DEVICE AT THAT POINT AND RV LEAD WAS REMOVED. UPON REMOVING LEADS FROM THE OLD DEVICE AND INSERTING INTO THE NEW DEVICE, THE DOCTOR AGAIN HAD PROBLEMS WITH THE SET SCREWS. THE PHYSICIAN WAS ADVISED TO INSERT THE WRENCH FIRST AND THEN INSERT THE LEADS, TO ALIGN WRENCH PERPENDICULAR AND LEADS IN PAST THE SCREW. THE PHYSICIAN WAS ABLE TO TIGHTEN AND HEAR RATCHET SOUND FOR RV LEAD BUT WAS NOT ABLE TO HEAR SOUNDS FOR THE OTHER TWO LEADS. THE PHYSICIAN PERFORMED TUG TEST AND LEADS DID NOT PULL OUT. TESTING WAS COMPLETED, AND ALL IMPEDANCES AND TESTING WERE COMPARABLE TO PREVIOUS DEVICE. THE NEW 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 7762760 ↗
• InjuryJul 27, 2018Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY HAD DEPLETED PREMATURELY. 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 7728386 ↗