Viva™ XT CRT-D DTBA1D1 (UDI 00643169530140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 333 adverse event reports that list this exact device (DI 00643169530140), received between Dec 9, 2016 and Sep 17, 2026 — classified as 8 deaths, 232 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (67 reports).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 3, 2021Class IOpen, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1306-2021 · Root cause: Device Design · Recall details · FDA record ↗

2. Dec 19, 2017Class ITerminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0584-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 333 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Battery Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) exhibited an alert for Recommended Replacement Time (RRT), low battery voltage. The CRT-D 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 50805924 ↗
• MalfunctionMay 4, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE MAY HAVE MISDETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) AS NON-SUSTAINED VENTRICULAR TACHYCARDIA. 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 25072611 ↗
• MalfunctionNov 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD AN ELECTROCARDIOGRAM AND WAS TOLD HIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS "NO LONGER WORKING". THE PATIENT HAD NOT HEARD ANY ALERT TONES. 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 23598730 ↗
• DeathNov 14, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY A PATIENT FAMILY REPRESENTATIVE THAT THE PATIENT WAS "SHOCKED FOR THE FIRST TIME EVER WHEN IN A POOL. THE NEW POOL WAS RESURFACED AND THEY REPLACED THE LIGHT AND IT WAS NOT GROUNDED PROPERLY WHEN IT HAPPENED." ADDITIONALLY, IT WAS STATED THAT THE PATIENT WENT TO THE EMERGENCY ROOM AND THE PHYSICIAN COULD NOT GET THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE IN A DIAGNOSTIC MODE. A FIELD REPRESENTATIVE ARRIVED AND PERFORMED A HISTOGRAM AND COULD SEE RIGHT AWAY WHEN THE STRAY VOLTAGE OCCURRED AND WHEN THE PATIENT GOT THE SHOCK. THE FAMILY REPRESENTATIVE ALSO STATED THAT THE INCIDENT IMPACTED QUALITY OF LIFE, AND AFTER THE INCIDENT THE PATIENT BECAME IRRITABLE AS IF EXPERIENCED POST-TRAUMATIC STRESS DISORDER, EXPERIENCED EYE PROBLEMS AND THREE EYE SURGERIES WITHIN THREE WEEKS. THE PATIENT FAMILY REPRESENTATIVE STATED KNOWS THAT ELECTRICAL SHOCKS CAN IMPACT THE EYE BUT NOT SURE IF IT WAS A DIRECT IMPACT AS THE PATIENT NEVER HAD EYE PROBLEMS BEFORE THE INCIDENT. IT WAS ALSO STATED THAT THE PATIENT PASSED AWAY "BUT FROM SOMETHING ELSE, NOT FROM THIS".

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23559830 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD PASSED OUT AND WAS TAKEN TO THE HOSPITAL WHERE IT WAS DISCOVERED THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD RAN OUT OF BATTERY. THE CRT-D WAS EXPLANTED AND REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 22692931 ↗
• InjuryJul 11, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 22479227 ↗
• InjuryJul 11, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING, TRIGGERING DEVICE-CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) AT TIMES. THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22479055 ↗
• MalfunctionApr 2, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IT WAS QUESTIONED IF NOISE WAS SEEN. A REVIEW OF THE DEVICE DATA WAS PERFORMED AND REVEALED THE EPISODES APPEAR TO SHOW 60HZ NOISE, THIS IS INDICATIVE OF ELECTRICAL NOISE, LIKELY SOMETHING POORLY GROUNDED IN PATIENT'S ENVIRONMENT. 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 21753660 ↗
• InjuryApr 1, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED POSSIBLE RAPID BATTERY DEP LETION. THE PATIENT EXPERIENCED EXTREME FATIGUE AND WAS FRAIL AND DEBILITATED. IT WAS NOTED THAT THE PATIENT WAS NOT DOING WELL AND THERE WERE CONCERNS ABOUT THE PATIENT'S HEALTH. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fatigue

  MAUDE report 21742372 ↗
• InjuryMar 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED FOR AN UNKNOWN ISSUE NOTED BY THE PHYSICIAN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560944 ↗
• InjuryDec 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED FOR NON-PROPHYLACTIC REASON, WAS NOT FUNCTIONING WITHIN NORMAL TOLERANCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS NO ISSUE WITH THE DEICE AND THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834449 ↗
• InjuryOct 22, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO A HEALTHCARE FACILITY EXPERIENCING UNCONSCIOUSNESS. INFORMATION RECEIVED INDICATED HEALTHCARE PROFESSIONAL "THINKING BATTERY IS GETTING LOW." THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. IT WAS ALSO REPORTED THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE INTERMITTENTLY UNDER SENSING NOTED ON STORED EPISODES AND CURRENT ELECTROGRAMS (EGM). THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 20509363 ↗
• InjuryJul 1, 2024Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE SUPRA VENTRICULAR TACHYCARDIA (SVT) DISCRIMINATOR THAT IS USED TO DISTINGUISH BETWEEN RAPID AND GRADUAL ONSET OF FAST VENTRICULAR RHYTHMS POTENTIALLY INAPPROPRIATELY WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT) AFTER CLASSIFYING IT AS SVT. 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: Tachycardia

  MAUDE report 19642801 ↗
• InjuryJun 28, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 19638032 ↗
• InjuryMay 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT FUNCTIONING WITHIN NORMAL TOLERANCES. THE CRT-D 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 19354611 ↗
• InjuryMar 26, 2024Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED RADIOFREQUENCY KYPHOPLASTY (RFK) WHICH WAS IDENTIFIED AS THE CAUSE OF THE CONFIRMED ELECTROMAGNETIC INTERFERENCE WHICH LEAD TO THE INAPPROPRIATE SHOCKS.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18981949 ↗
• InjuryMar 25, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS INAPPROPRIATE ANTI-TACHYCARDIA PACING AND HIGH VOLTAGE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF). THE DEVICE WAS EXPLANTED AND REPLACED THREE DAYS LATER DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18970871 ↗
• InjuryMar 23, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INAPPROPRIATELY WITHHELD THERAPY DUE TO THE DEVICE DISCRIMINATOR FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT IS USED TO DISTINGUISH BETWEEN RAPID AND GRADUAL ONSET OF FAST VENTRICULAR RHYTHMS.  IT WAS NOTED THAT THIS FEATURE IS USUALLY PROGRAMMED OFF.  THE DEVICE REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 18965235 ↗
• InjuryMar 7, 2024Pacing Problem; Pacing Problem

  ADDITIONALLY, THE CLINIC DISCLOSED THAT THE PATIENT WAS EXPERIENCING CARDIOGENIC SHOCK; HEART FAILURE; ACUTE RENAL FAILURE; ACUTE RESPIRATORY FAILURE; HYPERKALEMIA; HYPOMAGNESEMIA, AND HAD BEEN IN AND OUT OF ATRIAL FIBRILLATION. REPROGRAMMING WAS PERFORMED.

  Patient problems: Bradycardia

  MAUDE report 18857621 ↗
• InjuryFeb 15, 2024Failure to Deliver Shock/Stimulation; Pacing Problem; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING FOR VENTRICULAR TACHYCARDIA (VT) FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE CLINICIAN DID NOT BELIEVE THE PATIENT SHOULD HAVE RECEIVED THERAPY FOR T HIS EPISODE. THE CRT-D POTENTIALLY INAPPROPRIATELY WITHHELD THERAPY DUE TO DETECTION DISCRIMINATORS FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) AND SINUS TACHYCARDIA AND WAVELET THAT THE CLINICIAN THOUGHT SHOULD HAVE BEEN TREATED FOR VT. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 18713504 ↗
• MalfunctionFeb 12, 2024Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT REVIEW OF HIGH RATE NON-SUSTAINED (HRNS) EPISODES REVEALED RIGHT VENTRICULAR (RV) OVERSENSING THAT WAS SUSPECTED TO BE EXTERNAL ELECTROMAGNETIC INTERFERENCE (EMI). DURING IN-CLINIC TESTING, THE ISSUE COULD NOT BE REPRODUCED. 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 18691822 ↗
• InjuryDec 27, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). 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: Shock from Patient Lead(s)

  MAUDE report 18397733 ↗
• InjuryDec 18, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT SHORT CIRCUIT PROTECTION OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPROGRAMMED AND THE PATIENT WORE A LIFE VEST UNTIL 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 18347324 ↗
• InjuryNov 9, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND UNDEFINED IMPEDANCE ON THE RV DEFIBRILLATION COIL AND THE SUPERIOR VENA CAVA (SVC) COIL. IT WAS NOTED THAT AN RV COIL FRACTURE IS SUSPECTED. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE CRT-D DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE CRT-D AND RV LEAD REMAIN IN USE, HOWEVER, THE HIGH VOLTAGE THERAPIES WERE PROGRAMMED OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18100506 ↗
• InjuryNov 6, 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 EXPLANTED DUE TO THE INFECTION. IT WAS ALSO REPORTED THAT A SMALL PLEURAL EFFUSION AND PHYSIOLOGIC PERICARDIAL EFFUSION WERE NOTED THE SAME DAY AS THE EXPLANT PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion; Pleural Effusion; Unspecified Infection

  MAUDE report 18074420 ↗