Viva™ Quad S CRT-D DTBB1Q1 (UDI 00643169720206)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169720206), received between Oct 18, 2018 and Sep 24, 2024 — classified as 1 death, 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Electromagnetic Interference” (2 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-1743-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathSep 24, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT PASSED AWAY AND ALLEGES THAT "I DON'T THINK IT EVEN WORKED" AND THAT WHEN THE PATIENT PASSED AWAY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID NOT PROVIDE HIGH VOLTAGE THERAPY. THE CAUSE OF DEATH WAS OBTAINED FROM THE CORONERS OFFICE AND NOTED TO BE CARDIAC ARREST DUE TO CORONARY ARTERY DISEASE. ADDITIONAL INFORMATION RELATED TO THE DEATH WAS REQUESTED AND NOT RECEIVED.

  Patient problems: Cardiac Arrest

  MAUDE report 20290709 ↗
• InjuryOct 22, 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 (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). UNDERSENSING WAS ALSO NOTED 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: Shock from Patient Lead(s)

  MAUDE report 12685337 ↗
• MalfunctionSep 9, 2020Signal Artifact/Noise; Electromagnetic Interference; Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT A RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. ELECTROMAGNETIC INTERFERENCE AND SIXTY CYCLE NOISE WERE NOTED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) ATRIAL AND VENTRICULAR CHANNELS IN SEVERAL EPISODES, THE SOURCE OF WHICH WAS BELIEVED TO BE A POORLY GROUNDED SWIMMING POOL. THE ALERT HAD TRIGGERED APPROXIMATELY ONE YEAR EARLIER AS WELL BUT THE REASON FOR THE ALERT WAS NOT RECOGNIZED UNTIL THE CURRENT INSTANCE. IT WAS RECOMMENDED THAT THE PATIENT AVOID THE POOL UNTIL THE ELECTRICAL ISSUE HAS BEEN RESOLVED. THE ALERT TONES WERE RESET AND 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 10506510 ↗
• MalfunctionAug 12, 2020Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EMITTED A MAGNET TONE ON SEVERAL OCCASIONS. 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 10398690 ↗
• InjuryFeb 4, 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 EXPLANTED DUE TO SEPTICEMIA. CULTURES WERE TAKEN AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 9664816 ↗
• MalfunctionMay 8, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO REPLACEMENT PROCEDURE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS INTERROGATED AND THE BATTERY LONGEVITY STATUS BAR WAS GRAY. IT WAS NOTED THAT THE GRAY BAR AND BATTERY VOLTAGE REMAINED THE SAME AFTER THREE INTERROGATION ATTEMPTS. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8592753 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION OF THE HEART THE MONTH FOLLOWING CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM IMPLANT WITH AN ABSORBABLE ENVELOPE. THE SYSTEM WAS REMOVED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8561310 ↗
• InjuryOct 18, 2018Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT POST-OPERATIVE TO A ROUTINE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CHANGE-OUT PROCEDURE, THE VECTOR EXPRESS ALGORITHM WAS RUN, BUT THE ALGORITHM COULD NOT EXECUTE DUE TO A FAST/COMPETING RHYTHM SO THE MEDICAL EQUIPMENT COMPANY REPRESENTATIVE SELECTED OK, BUT THEN NOTICED A-V DISSOCIATION BECAUSE THE PACING MODE - WHICH HAD BEEN PROGRAMMED TO A DUAL SENSING AND PACING MODE (DDD) - WAS NOW A VENTRICULAR-ONLY SENSING AND PACING MODE (VVI.) THE REPRESENTATIVE OBSERVED VVI PACING FOR ABOUT ONE MINUTE AND THEN REPROGRAMMED THE DEVICE PACING MODE FROM DDD TO VVI AND BACK TO DDD, WHICH THEN CAUSED NORMAL DDD PACING. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7978726 ↗