Viva™ Quad S CRT-D DTBB1QQ (UDI 00643169530218)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00643169530218), received between Dec 9, 2016 and Sep 7, 2023 — classified as 1 death, 23 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (7 reports).

2 FDA recall records 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. Feb 3, 2021Class IOpen, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1306-2021 · Root cause: Device Design · Recall details · FDA record ↗

2. Dec 19, 2017Class ITerminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0584-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 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 17698609 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THERE WAS A LEAD FAILURE.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 17131012 ↗
• InjuryApr 26, 2023Adverse 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 AN INFECTION. 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: Unspecified Infection

  MAUDE report 16815028 ↗
• MalfunctionApr 14, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT HEART RATE WAS NOTED TO INTERMITTENTLY BE 30-35 BEATS PER MINUTE HOWEVER THE DEVICE PROGRAMMED LOWER RATE IS SET TO 60 BEATS PER MINUTE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 16743722 ↗
• InjuryNov 22, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED BY A REPRESENTATIVE FOR THE PATIENT THAT THE PATIENT HAD A "TERRIBLE IMPLANTED DEVICE EPISODE (EXPERIENCE);" THE REPRESENTATIVE INDICATED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD "BLOWN UP" IN THE PATIENT'S CHEST AND "SPARKS WERE FLARING OUT OF THEIR CHEST." IT WAS NOTED THE PATIENT WAS BROUGHT TO THE HOSPITAL AND HAD AN EMERGENCY DEVICE REPLACEMENT AS ARESULT OF THE EVENT. ADDITIONAL DETAILS WERE REQUESTED PERTAINING TO THE EVENT, HOWEVER, FOLLOW-UP IS NOT AVAILABLE AT THIS TIME. THE CRT-D WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15845283 ↗
• InjuryAug 16, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE EXHIBITED EARLY 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 15236576 ↗
• InjuryMay 20, 2022Battery Problem; Battery Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14452517 ↗
• InjuryNov 18, 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 EXPLANTED DUE TO A BACTEREMIA INFECTION. A REPLACEMENT LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12836590 ↗
• InjurySep 17, 2020Mechanical Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Mechanical Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED HIGH VOLTAGE THERAPY FOR PAROXYSMAL ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT ACCELERATED TO VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD AND NO CAPTURE. A REVISION PROCEDURE WAS SCHEDULED. IT WAS ALSO REPORTED THAT DURING THE PROCEDURE, A LEFT VENTRICULAR SETSCREW PROBLEM WAS NOTED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THAT CAUSED THE LV LEAD TO BE LOSE INSIDE THE HEADER. DURING THE LV EXPLANT, EXTRACTION DIFFICULTY WAS ENCOUNTERED. THE PHYSICIAN USED A LOCKING STYLET AND THE LEAD WAS SUCCESSFULLY REMOVED. A NEW LV LEAD WAS IMPLANTED. THE CRT-D WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 10551259 ↗
• MalfunctionAug 4, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED POSSIBLE PREMATURE BATTERY DEPLETION. 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 10365418 ↗
• MalfunctionJun 17, 2020Signal 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 A LEAD INTEGRITY ALERT (LIA) THAT WAS CAUSED BY THE PATIENT USING A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT. THE ALERT WAS PROGRAMMED OFF 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 10161975 ↗
• InjuryApr 14, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY DUE TO SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS ADDITIONALLY NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD GAVE AN IMPEDANCE WARNING. THE DEVICE AND 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 9959170 ↗
• InjuryMar 6, 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 A BACTEREMIA INFECTION. THE PATIENT IS TO RECEIVE A NEW SYSTEM AT A FUTURE DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9800233 ↗
• MalfunctionJan 27, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), AS THE PATIENT STATED LAST TIME THE DEVICE WAS CHECKED IT SHOWED 7 YEARS NOW IT'S SHOWING A LITTLE OVER 3 YEARS. 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 9633483 ↗
• InjuryDec 30, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE REACHED POSSIBLE EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9532601 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AND WAS FOUND TO HAVE A SYSTEMIC INFECTION WITH VEGETATION NOTED ON THE LEADS. CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXTRACTION WAS TEMPORARILY POSTPONED DUE TO PULMONARY EDEMA AND THE SYSTEM WAS SUBSEQUENTLY REMOVED. THE PATIENT RECEIVED A NEW SYSTEM APPROXIMATELY TWO WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pulmonary Edema; Unspecified Infection

  MAUDE report 9327731 ↗
• DeathAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ALSO DIAGNOSED WITH BACTEREMIA/SEPTICEMIA.

  Patient problems: Chills; Death; Diarrhea; Endocarditis; Fever; Infarction, Cerebral; Nausea; Unspecified Infection

  MAUDE report 8913263 ↗
• MalfunctionAug 5, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT SHORT V-V INTERVALS WERE NOTED. IT WAS THOUGHT THAT THEY OCCURRED DURING AN ABLATION PROCEDURE. THE PATIENT¿S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 8861518 ↗
• InjuryJul 19, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT DURING A STRESS TEST FOR A PATIENT WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD), THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED VENTRICULAR FIBRILLATION (VF) - WHICH MAY HAVE BEEN SUPRA VENTRICULAR TACHYCARDIA (SVT) WITH 1:1 CONDUCTION - AND A SHOCK WAS DELIVERED. IT WAS ALSO REPORTED THAT ABOUT FIVE MONTHS PRIOR, TWO NON-SUSTAINED HIGH RATE EPISODES SHOWED RIGHT VENTRICULAR LEAD OVERSENSING. THE DEVICE AND 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 8807562 ↗
• MalfunctionMay 9, 2019Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT HEARD THEIR DEVICE TONE BECAUSE THEY "GOT TOO CLOSE TO A MAGNET." 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 8595262 ↗
• InjuryApr 26, 2019Premature 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 Known Impact Or Consequence To Patient

  MAUDE report 8555666 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BACTERIEMIA INFECTION. ANTIBIOTIC TREATMENT WAS NECESSARY. THE DEVICE AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7848108 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S SYSTEM WAS REMOVED.

  Patient problems: Cellulitis; Chest Pain; Erythema; Unspecified Infection

  MAUDE report 7546486 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. THE DEVICE REMAINS IN USE. THE PATIENT IS ENROLLED IN THE PRODUCT SURVEILLANCE REGISTRY CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7418794 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN RESPONSE TO THE ADVISORY NOTING THE POTENTIAL FOR INTERNAL DEVICE ARCING DURING HIGH-VOLTAGE CHARGING, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROPHYLACTICALLY REPLACED. NO DEVICE MALFUNCTION WAS OBSERVED WHILE THE DEVICE WAS IN USE, HOWEVER, GIVEN THE POTENTIAL FOR LOSS OF DEVICE FUNCTIONALITY, THE CRT-D WAS EXPLANTED AND REPLACED TO PRECLUDE HARM TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7416117 ↗