Viva™ Quad S CRT-D DTBB1QQ (UDI 00643169720145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169720145), received between Nov 29, 2018 and Aug 20, 2025 — classified as 1 death, 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 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-1744-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE HAD POSSIBLE ARTIFACT/INTERFERENCE NOTED ON ELECTROGRAMS. THE CRT-D 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 22854145 ↗
• DeathMay 11, 2023Battery Problem; Battery Problem

  IT WAS FURTHER REPORTED BY THE FOLLOW UP CLINIC THAT THE CAUSE OF THE PATIENT'S DEATH WAS UNKNOWN AND THERE WERE NO ISSUES NOTED WITH THE BATTERY ON THE PATIENT'S LAST INTERROGATION. IT WAS ALSO NOTED THAT THEY DID NOT SUSPECT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Insufficient Information

  MAUDE report 16911717 ↗
• InjuryDec 12, 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 METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS, SEPSIS, AND BACTEREMIA. A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Sepsis; Unspecified Infection

  MAUDE report 15957925 ↗
• InjuryAug 11, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION.  IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND THE LEFT VENTRICULAR (LV) LEAD HAD EXHIBITED HIGH THRESHOLDS SINCE IMPLANT.  THE LV LEAD THRESHOLD SETTING WAS RE-PROGRAMMED.  THE RA LEAD 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 15209558 ↗
• MalfunctionNov 7, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS CONCERNS FOR PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). A REVIEW OF A TRANSMISSION SHOWED HIGH OUTPUTS AND LOW IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD. FOLLOW UP YIELDED NO INFORMATION. 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 12759832 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT IT WAS DETERMINED THAT THE SOURCE OF THE BACTEREMIA WAS DISCITIS AND OSTEOMYELITIS OF THE LUMBAR VERTEBRA.

  Patient problems: Unspecified Infection

  MAUDE report 12583460 ↗
• InjuryAug 7, 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 (B)(6) INFECTION. A RIGHT VENTRICULAR (RV) LEAD WHICH WAS PREVIOUSLY CAPPED DUE TO AN UPGRADE BROKE DURING EXPLANT AND THE PHYSICIAN WAS UNABLE TO SNARE THE REMNANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10378097 ↗
• MalfunctionMar 5, 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 9792828 ↗
• MalfunctionFeb 18, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE DEVICE WAS INTERROGATED AND THE BATTERY VOLTAGE WAS BELOW THE LEVEL INDICATED FOR IMPLANT. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9721584 ↗
• InjuryJul 17, 2019Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF CAPTURE AND PAUSES NOTED ON A TELEMETRY STRIP. FOLLOW UP CONCLUDED THIS WAS DUE TO VARIABLE RIGHT VENTRICULAR (RV) LEAD THRESHOLDS, THE RV LEAD OUTPUT WAS POSSIBLY BELOW THE THRESHOLD, AND THE DEVICE FEATURE THAT MONITORS THE PACING AMPLITUDE THRESHOLD AND ADJUSTS RV LEAD OUTPUTS. THE DEVICE WAS REPROGRAMMED AND EXPLANTED AND REPLACED. THE RV LEAD WAS REPROGRAMMED, REVISED, AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 8798401 ↗
• MalfunctionMar 28, 2019Premature Discharge of Battery; Electrical /Electronic Property Problem; Premature Discharge of Battery; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION AS IT MEASURED A BATTERY VOLTAGE BELOW INDICATION FOR IMPLANT. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8461899 ↗
• InjuryNov 29, 2018Adverse 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 SYSTEMIC INFECTION. A TEMPORARY PACING SYSTEM WAS UTILIZED FOR APPROXIMATELY ONE WEEK UNTIL A NEW SYSTEM COULD BE IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8118182 ↗