Viva™ XT CRT-D DTBA1D4 (UDI 00643169720251)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00643169720251), received between Aug 16, 2018 and May 14, 2026 — classified as 1 death, 25 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (8 reports).

1 FDA recall record 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. May 10, 2023Class IOpen, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1731-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE 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 25176486 ↗
• InjurySep 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS AN INCREASE IN LEFT VENTRICULAR (LV) LEAD THRESHOLD MEASUREMENTS NOTED ON LEAD TRENDS. IT WAS ALSO NOTED THAT THE PATIENT WAS RECENTLY IN THE INTENSIVE CARE UNIT (ICU) DUE TO A DEVICE MALFUNCTION. THE LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 23102894 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION ENDOCARDITIS. THE ORGANISM WAS IDENTIFIED AS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS. 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: Bacterial Infection; Endocarditis

  MAUDE report 20348658 ↗
• DeathApr 25, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT IS DECEASED. THE CAUSE OF DEATH WAS REQUESTED BUT COULD NOT BE OBTAINED.

  Patient problems: Insufficient Information; Shock from Patient Lead(s)

  MAUDE report 19183876 ↗
• InjuryAug 21, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE BATTERY DEPLETION. 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 17583581 ↗
• InjuryAug 9, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED, THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). HAD PREMATURE BATTERY DEPLETION. 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 17494706 ↗
• InjuryFeb 16, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED SEVERAL INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE 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 16387502 ↗
• InjuryDec 1, 2022Adverse 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15900740 ↗
• InjuryOct 21, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CARDIAC ARREST. AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED THAT SHORT CIRCUIT PROTECTION OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY. IT WAS NOTED THAT NONE OF THE HIGH VOLTAGE THERAPIES APPEARED TO CONVERT THE RHYTHM. THE DEVICE REMAINS IN USE. THIS INCIDENT WAS NOT REPORTED BY A HEALTH CARE PROVIDER; THEREFORE, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Cardiac Arrest

  MAUDE report 15655278 ↗
• InjuryJan 24, 2022Adverse 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. A NEW SYSTEM WAS IMPLANTED THE FOLLOWING WEEK. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13338351 ↗
• InjuryJan 11, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A GRAY BAR INDICATING LOW BATTERY VOLTAGE. THE PATIENT WAS SEEN TO INTERROGATE THE DEVICE AND IT WAS NOTED THE DETECTIONS AND THERAPIES HAD BEEN ELECTIVELY TURNED OFF SINCE IMPLANT BY REQUEST OF THE PATIENT. A PROGRAMMER SESSION WAS INITIATED, IN WHICH DETECTIONS/THERAPIES WERE TURNED ON, THEN OFF AND ON AGAIN. THE PROGRAMMER SESSION WAS ENDED AND THE DEVICE WAS INTERROGATED ONCE AGAIN. THE GRAY BAR WAS NO LONGER OBSERVED FOLLOWING THE PROGRAMMER SESSION AND THE DEVICE BEGAN THE "IMPLANT INITIALIZATION" PROCESS. 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 13218610 ↗
• InjuryMay 27, 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 REMOVED DUE TO INFECTION. THE LEFT VENTRICULAR (LV) LEAD WAS PARTIALLY REMOVED WITH THE REMAINDER BEING CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11897580 ↗
• InjuryFeb 8, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO HAVE HIGH THRESHOLDS. THE ICD WAS EXPLANTED AND REPLACED AND 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 11295615 ↗
• MalfunctionJan 4, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A PRE-IMPLANT DEVICE CHECK, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED A BATTERY VOLTAGE THAT DID NOT MEET INDICATIONS FOR IMPLANT UPON DEVICE INTERROGATION. THE DEVICE WAS STORED AND RE-INTERROGATED AT A LATER DATE, BUT THE ISSUE PERSISTED. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11110181 ↗
• MalfunctionDec 28, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A PRE-IMPLANT DEVICE CHECK, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED A BATTERY VOLTAGE THAT DID NOT MEET INDICATIONS FOR IMPLANT UPON DEVICE INTERROGATION. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077631 ↗
• InjuryNov 17, 2020Adverse 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 POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10850233 ↗
• MalfunctionOct 30, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THE BATTERY LIFE ON THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS "DRAINING TOO FAST" AND THAT THE "DEVICE WAS BURNING OUT." THE CRT-D REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10762790 ↗
• InjuryOct 8, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IT WAS NOTED THAT THE ASSOCIATED COMPETITOR LEFT VENTRICULAR (LV) LEAD THRESHOLD SPIKED, AND WAS HIGH, AS A RESULT THE CRT-D EXHIBITED UNEXPECTED PREMATURE BATTERY DEPLETION. THE CRT-D SETTINGS WERE RE-PROGRAMMED AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10651925 ↗
• InjuryOct 1, 2020Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FROM THEIR CRT-D (CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR) WHILE USING A WEED EATER. THE 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 10612799 ↗
• MalfunctionSep 21, 2020Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Protective Measures Problem; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Protective Measures Problem

  IT WAS REPORTED BY THE PATIENT THEY HAD A ROUTINE FOLLOW-UP APPOINTMENT WHERE "CHANGES WERE MADE." AFTER THE APPOINTMENT, THE PATIENT REPORTED HEARING "BEEPING" FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS FURTHER REPORTED BY THE CLINIC THAT THE CAUSE OF THE BEEPING WAS POTENTIALLY DUE TO MAGNET EXPOSURE AS NO ALERTS WERE NOTED ON THE DEVICE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10562875 ↗
• InjurySep 10, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE DELIVERED AN INAPPROPRIATE SHOCK FOR AN ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE EPISODE THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE HIGH THRESHOLDS. THE CRT-D AND LV LEAD 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 10513808 ↗
• InjuryMay 29, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE DELIVERED A SHOCK FOR A SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED DOUBLE COUNTING OF A COUPLE BEATS AFTER THE SHOCK WAS DELIVERED. THE CRT-D AND THE RV 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 10101509 ↗
• MalfunctionApr 27, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A LOW TELEMETRY BATTERY VOLTAGE INDICATOR PRIOR TO IMPLANT. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10002074 ↗
• InjuryApr 22, 2020Adverse 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 A LEFT PECTORAL SUBCUTANEOUS POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9987041 ↗
• InjuryApr 8, 2020Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING AND HIGH VOLTAGE THERAPY FROM THE CARDIAC R ESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). THE CRT-D REMAINS IN USE. INTERMITTENT UNDERSENSING WAS ALSO NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE LEAD RE MAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 9941830 ↗