Viva™ XT CRT-D DTBA1D1 (UDI 00643169720312)Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00643169720312), received between Sep 20, 2018 and Jul 2, 2026 — classified as 2 deaths, 45 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (13 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-1729-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POSSIBLY DELIVERED AN INAPPROPRIATE SHOCK FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE CRT-D DETECTED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). THE ICD 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 25697320 ↗
• InjuryOct 13, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MISCLASSIFYING AN EPISODE SUPRA VENTRICULAR TACHYCARDIA (SVT) AS VENTRICULAR TACHYCARDIA (VT). 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 20436277 ↗
• InjurySep 26, 2024Premature 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20312005 ↗
• InjurySep 24, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR A SUSPECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE THAT WAS DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. 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 20294328 ↗
• InjurySep 6, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT POSSIBLY RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR AN ATRIAL ARRYTHMIA WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED 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 20163242 ↗
• InjuryMar 13, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TACHYCARDIA. THE PATIENT RECEIVED POTENTIALLY INAPPROPRIATE ANTI-TACHYCARDIA PACING AND A SHOCK FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT THE THERAPY WAS INITIALLY APPROPRIATELY WITHHELD FOR THE AF DISCRIMINATOR. 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 18899147 ↗
• InjuryFeb 23, 2024Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POSSIBLY INAPPROPRIATELY WITHHELD THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION (VT/VF). ADDITIONALLY, IT WAS NOTED THAT THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 18768579 ↗
• InjuryAug 17, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IT WAS NOTED THAT THERAPY POTENTIALLY INAPPROPRIATELY WITHHELD BY THE SINUS TACHYCARDIA DISCRIMINATOR FEATURE DURING AN SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE. 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 17567118 ↗
• InjuryJul 14, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. 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 17328600 ↗
• InjuryJun 22, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THERE WAS A POSSIBLE MALFUNCTION OR DEFECT WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY. 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 17186844 ↗
• InjuryMay 24, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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 16991904 ↗
• InjuryApr 4, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD A LEAD WIRE THAT WAS DEFECTIVE, WHICH RESULTED IN MORE OF A DRAW ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY THAN IF THE LEAD WIRE WAS NOT DEFECTIVE.  THE DEVICE WAS EXPLANTED AND REPLACED. AND THE LEFT VENTRICULAR (LV) 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 16676349 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE AN INFECTION OCCURRED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 16637019 ↗
• InjuryFeb 16, 2023Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: Strangulation

  MAUDE report 16390346 ↗
• InjuryFeb 15, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING USE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE CRT-D WAS EXPLANTED AND REPLACED. THE RV LEAD AND LV LEAD PACING OUTPUTS WERE OPTIMIZED AND THE LEADS 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 16378241 ↗
• MalfunctionNov 4, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED THAT SHORT CIRCUIT PROTECTION OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY. DURING THE IMPLANT PROCEDURE VENTRICULAR FIBRILLATION (VF) WAS INDUCED AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROVIDED TWO HIGH VOLTAGE THERAPY WITH LOW ENERGY. THE LEAD WAS CHANGED AND A FULL ENERGY SHOCK WAS DELIVERED AS EXPECTED. THE DEVICE REMAINS IN USE. THIS INCIDENT WAS NOT REPORTED BY A HEALTH CARE PROVIDER; THEREFORE, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15737467 ↗
• InjurySep 24, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD CHRONICALLY ELEVATED THRESHOLD MEASUREMENTS.  DURING THE LEAD REVISION, THE PHYSICIAN NOTICED EXTENSIVE COILING OF THE LEADS AND MIGRATION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DOWN IN THE CHEST AND LATERAL AREA.  IT WAS NOTED THAT APPROXIMATELY TWO HOURS WERE SPENT FREEING NUMEROUS LEADS OF ADHESIONS.  THE LEADS WERE ABOVE THE DEVICE AND THE OTHER LEADS WERE LOOPED IN A COMPLEX MANNER BENEATH THE DEVICE.  THE PHYSICIAN TOOK CAUTION TO AVOID POTENTIALLY DAMAGING OF THE LEADS.  IT WAS ALSO NOTED THAT THE VEIN WAS STENOSED BASED ON THE VENOGRAM THAT WAS DONE BEFORE.  THE LEAD WAS CAPPED AND REPLACED, AND 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 15477735 ↗
• InjuryAug 26, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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 15301191 ↗
• MalfunctionJul 6, 2022Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THERE WAS A 60HZ NOISE ON THE ATRIAL CHANNEL OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE AND THE ELECTROMAGNETIC INTERFERENCE WAS SUSPECTED TO BE FROM AN EXTERNAL SOURCE. 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 14929981 ↗
• MalfunctionJun 30, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP WITH THE PATIENT, THE ESTIMATED BATTERY LIFE WAS SHORTER THAN THE PATIENT HAD EXPECTED. 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 14880906 ↗
• InjuryMay 26, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED UNEXPECTED LONGEVITY BASED ON PRIOR LONGEVITY ESTIMATES. HIGH OUTPUTS WERE NOTED ON THE LEFT VENTRICULAR (LV) LEAD, AND OUTPUTS WERE NOTED TO HAVE BEEN PROGRAMMED UPWARD. THE CRT-D AND LV LEAD 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 14518587 ↗
• MalfunctionDec 15, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  FOLLOW-UP CONCLUDED THAT THE DEVICE WAS FUNCTIONING APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010747 ↗
• MalfunctionNov 29, 2021Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN NEAR THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SITE. THE DEVICE WAS SUSPECTED OF POSSIBLE PREMATURE VENTRICULAR BEATS. VENTRICULAR CAPTURE WAS UNABLE TO BE CONFIRMED. THE DEVICE REMAINS IN USE. IT WAS ALSO NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED VARIABLE CAPTURE THRESHOLD MEASUREMENTS ON LEAD TRENDS. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT VENTRICULAR CAPTURE WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883286 ↗
• MalfunctionSep 17, 2021Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THERE WAS POSSIBLE DEVICE NON-CAPTURE AND FAILURE TO SENSE. AN INTERROGATION INDICATED THERE WAS POSSIBLE UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD PREVENTING A MODESWITCH. THE DEVICE AND LEAD 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 12488740 ↗
• InjuryJul 9, 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 INFECTED WITH VEGETATION ON THE LEADS. LOW P-WAVES WERE ALSO NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE SYSTEM REMAINS IS USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12141819 ↗