Viva™ Quad S CRT-D DTBB1QQ (UDI 00643169929401)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169929401), received between Dec 7, 2017 and Jun 17, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ACTIVELY PROVIDING HIGH VOLTAGE THERAPY DESPITE MAGNET APPLICATION. IT WAS CONFIRMED THAT THE HEALTHCARE PROFESSIONAL PLACED THE DONUT MAGNET OVER THE CRT-D, AND IT CAUSED A TONE. 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 22256869 ↗
• InjuryMay 6, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED 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 14305737 ↗
• InjuryDec 21, 2021Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY DUE TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTING ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT THE PATIENT HAD A SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE THAT TRANSITIONED INTO VENTRICULAR FIBRILLATION (VF) AND THERAPIES WERE WITHHELD. 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); Ventricular Fibrillation

  MAUDE report 13052093 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SUSPECTED POCKET INFECTION.  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12830220 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE DEVICE AND LEADS WERE EXPLANTED AND REPLACED FOUR DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9438639 ↗
• MalfunctionApr 25, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SET SCREW BACKED OUT OF THE HEADER AND FELL OUT OF THE DEVICE. THE DEVICE WAS NOT USED, AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8553019 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HEMATOMA HAD POST-OPERATIVELY DEVELOPED AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT SITE DUE TO ANTICOAGULANT USE. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED SWELLING AND PAIN. A POCKET EVACUATION WAS PERFORMED AND THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Pain; Swelling

  MAUDE report 7092102 ↗