Viva™ Quad XT CRT-D DTBA1QQ (UDI 00643169720138)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00643169720138), received between Jul 11, 2018 and May 20, 2026 — classified as 24 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (7 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-1733-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT STORED EPISODES REVEALED ELECTROMAGNETIC INTERFERENCE (EMI) AND NOISE THAT TRIGGERED EPISODE MISCLASSIFICATION. 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 25229202 ↗
• InjuryJul 21, 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 FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). THE RIGHT VENTRICULAR (RV) LEAD APPEARED TO BE OVERSENSING AND UNDERSENSING AND THERE WAS AN OBSERVATION FOR T-WAVE OVERSENSING (TWOS). UNDERSENSING WAS ALSO NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE CRT-D, RV LEAD, 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 22555783 ↗
• MalfunctionJan 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT¿S FAMILY MEMBER WAS CONCERNED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING AND THAT THE PATIENT WAS TOO BRADYCARDIC. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21253598 ↗
• MalfunctionOct 18, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA THAT WAS BELOW THE LOWER PROGRAMMED RATE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE BRADYCARDIA WAS NOTED ON EXTERNAL TELEMETRY. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 17959810 ↗
• InjurySep 28, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED POSSIBLE EARLY 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17835253 ↗
• MalfunctionMar 3, 2023Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD ON THE RIGHT ATRIAL (RA) LEAD. ADDITIONALLY, IT WAS NOTED THE PATIENT RECEIVED A POSSIBLE ANTI-TACHYCARDIA PACING FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). THE LEAD 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 16478694 ↗
• MalfunctionJan 20, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT NOISE AND OVERSENSING WERE OBSERVED DURING TWO HIGH RATE NON-SUSTAINED EPISODES. THE PATIENT WAS SEEN AT THE CLINIC, AND ISOMETRICS AND POCKET STIMULATION WERE PERFORMED. IT WAS DETERMINED THAT THE CAUSE OF THE NOISE OVERSENSING WAS ELECTROMAGNETIC INTERFERENCE (EMI). NO PROGRAMMING CHANGES WERE MADE AND 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 16218070 ↗
• MalfunctionNov 10, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS FURTHER REPORTED THE PATIENT MENTIONED TO THE NURSE THAT THEY HAD A SIMILAR CHALLENGE GETTING THE CRT-D INTERROGATED AT THE PATIENTS PREVIOUS APPOINTMENT, SIX MONTHS EARLIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770839 ↗
• InjuryNov 3, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POTENTIALLY INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 15722064 ↗
• InjurySep 14, 2022Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING WHILE THE PATIENT WAS WORKING ON COPPER SINK PLUMBING NEAR ELECTRICAL WIRING. THE PATIENT REPORTED FEELING "WEIRD" WITH PALPITATIONS AND LIGHT HEADEDNESS. THE PATIENT'S MEDICATION WAS ADJUSTED AND THE CRT-D WAS REPROGRAMMED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Dyspnea

  MAUDE report 15420490 ↗
• InjuryAug 10, 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 EXPLANTED DUE TO INFECTION AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15202414 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE POCKET OPENED UP DUE TO LONG TERM STEROID USE AND THIN SKIN. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION AND ANTIBIOTIC TREATMENT WAS ADMINISTERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 14435895 ↗
• MalfunctionDec 10, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY WAS DEPLETING FASTER THAN ANTICIPATED. 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 12976471 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED DUE TO AN INFECTION, AND TRICUSPID REGURGITATION RESTRICTED BY THE RIGHT VENTRICULAR (RV) LEAD AND THEN REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12865930 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ENTEROCOCCUS BACTEREMIA INFECTION. THE SOURCE OF THE INFECTION COULD NOT BE FOUND. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. A NEW CRT-D SYSTEM WAS IMPLANTED ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 12704260 ↗
• InjuryAug 2, 2021Premature 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 12264134 ↗
• InjuryJun 11, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK. AN INTERROGATION SHOWED THERE WAS HIGH THRESHOLD AND LIMITED VECTORS CAPTURED ON THE LEFT VENTRICULAR (LV) LEAD. THERE WAS POSSIBLE T-WAVE OVERSENSING (TWOS) AND UNDERSENSED R-WAVES DURING VENTRICULAR TACHYCARDIA(VT) ON THE RIGHT VENTRICULAR (RV) LEAD. A LIA TRIGGERED ON THE RV LEAD DUE HIGH RATE NON-SUSTAINED EPISODES. THERE WAS PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS NOTED THE PATIENT RECEIVED INAPPROPRIATE THERAPY. THE LV LEAD WAS CAPPED AND WAS ATTEMPTED TO BE REPLACED, HOWEVER, THE LEAD WAS UNABLE TO CAPTURE. THE LV LEAD WAS REMOVED. THE RV LEAD WAS CAPPED AND REPLACED. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11983466 ↗
• InjuryMay 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 INFECTION. THE ENTIRE 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 11886090 ↗
• InjuryMay 19, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE BEEN INAPPROPRIATELY SHOCKED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS VENTRICULAR TACHYCARDIA. 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 11851725 ↗
• MalfunctionApr 19, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE DEVICE WAS ALLOWING THE PATIENT'S HEART RATE TO DROP INTO THE 30S, WHICH WAS BELOW THE PROGRAMMED LOWER RATE. 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 11685276 ↗
• MalfunctionMar 25, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11569292 ↗
• MalfunctionFeb 10, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A LONGEVITY ESTIMATE THAT WAS LESS THAN EXPECTED. FOLLOW UP YIELDED NO INFORMATION. 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 11307389 ↗
• MalfunctionJan 25, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A GREY BAR BATTERY MEASUREMENT. THE DEVICE WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11222610 ↗
• InjuryJan 22, 2021Signal Artifact/Noise; Failure to Deliver Shock/Stimulation; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Failure to Deliver Shock/Stimulation; Electromagnetic Interference; Over-Sensing

  FOLLOW UP REVEALED THE INTERFERENCE EPISODES CORRESPONDED WITH THE PATIENT BEING CLOSE TO POWERLINES IN THEIR RECREATIONAL VEHICLE. THE DEVICE WAS REPROGRAMMED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 11214603 ↗
• MalfunctionNov 25, 2020Data Problem; Data Problem

  IT WAS FURTHER REPORTED THAT THE LONGEVITY ESTIMATE WAS DUE TO A REMOTE MONITORING NETWORK SOFTWARE ESTIMATOR ERROR. A CORRECT ESTIMATE HAS BEEN OBTAINED WITH UPDATED SOFTWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905954 ↗