Viva™ Quad S CRT-D DTBB1QQ (UDI 00643169007161)Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00643169007161), received between Dec 9, 2016 and Apr 23, 2024 — classified as 3 deaths, 80 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (25 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. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI)/RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19167027 ↗
• InjuryOct 14, 2022Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE SCHEDULED TESTING OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FEATURE WHICH MONITORS PACING THRESHOLDS AT PERIODIC INTERVALS WORSENED THE PATIENT'S EXISTING ARRHYTHMIA. THE RHYTHM EVENTUALLY FELL IN TO THE VENTRICULAR FI BRILLATION (VF) ZONE AND WAS TREATED WITH THE PROGRAMMED SHOCK THERAPY. 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); Ventricular Fibrillation

  MAUDE report 15609535 ↗
• MalfunctionSep 2, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT CAPTURING. 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 15346539 ↗
• MalfunctionJun 28, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ODDLY PACING. IT WAS NOTED THAT THE DEVICE DISPLAYED A LOT OF PACING SPIKES IN A ROW ON THE MONITOR. 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 14843408 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14748313 ↗
• InjuryApr 21, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A CHARGE CIRCUIT TIMEOUT AND THE RIGHT VENTRICULAR (RV) LEAD HAD A POSSIBLE FRACTURE, INAPPROPRIATE SHOCKS FOR OVERSENSING, SENSING INTEGRITY COUNTER (SIC), AN RV LEAD NOISE WARNING, AND A LEAD INTEGRITY ALERT (LIA) TRIGGERED. THE CRT-D AND RV LEAD WERE REPROGRAMMED, A MAGNET WAS PLACED ON THE DEVICE AND BOTH THE CRT-D AND RV LEAD WERE REPLACED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14169097 ↗
• MalfunctionApr 7, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A ROUTINE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CHANGEOUT PROCEDURE, THE EXPLANTING PHYSICIAN TRIED TO REMOVE THE ONE OF THE LEADS FROM THE DEVICE HEADER USING A COMPETITOR ALLEN WRENCH. THE PHYSICIAN WAS UNABLE TO ENGAGE THE SETSCREW TO REMOVE THE LEAD. TWO OTHER DIFFERENT ALLEN WRENCHES WERE ATTEMPTED WITH THE SAME RESULT. IT WAS NOTED THAT THE OTHER LEADS WERE ABLE TO BE REMOVED FROM THE HEADER USING THE SAME ATTEMPTED ALLEN WRENCHES. AFTER CONSULT WITH TECHNICAL SERVICES, THE PHYSICIAN AGREED TO REMOVE THE SILICON COVER FROM THE GROMMET TO OBSERVE THE SETSCREW. AFTER REMOVAL, THE SETSCREW APPEARED ¿CROOKED AND TILTED AT AN ANGLE¿. WHEN THE PHYSICIAN ATTEMPTED TO ADJUST THE SETSCREW WITH THE WRENCH AGAIN, THE SETSCREW ¿POPPED OUT OF THE DEVICE AND FLEW ON THE TABLE¿. THE DEVICE WAS THEN SUCCESSFULLY 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 14047329 ↗
• InjuryFeb 14, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR WHAT APPEARED TO BE ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) EPISODES DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. 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)

  MAUDE report 13524796 ↗
• InjuryJan 21, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE SHOCKS FOR AN ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE DETECTED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS VENTRICULAR FIBRILLATION (VF). THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 13317152 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A 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 12862882 ↗
• InjuryNov 23, 2021Mechanical Problem; Connection Problem; Mechanical Problem; Connection Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD FROM THE HEADER OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LV PORT SETSCREW WAS EASILY LOOSENED BUT THE LEAD COULD NOT BE PULLED FROM THE HEADER. THE RV PORT SETSCREW FELT LIKE THE WRENCH COULD NOT BE INSERTED. THE SILICONE FROM THE HEADER WAS REMOVED AND THE SETSCREWS WERE THEN RETRACTED. IT WAS NOTED THAT IT STILL TOOK A LOT OF FORCE TO REMOVE THE LEADS FROM THE HEADER. THE LEADS WERE ELECTRICALLY TESTED AND CONFIRMED ADEQUATE FUNCTION. THE CRT-D WAS EXPLANTED AND REPLACED. THE LV AND RV LEADS 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 12861520 ↗
• InjuryOct 29, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; 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 AN ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE THAT WAS CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). 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)

  MAUDE report 12722278 ↗
• InjuryOct 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE HAD A POTENTIAL PERFORMANCE ISSUE AND 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 12615092 ↗
• InjuryOct 6, 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 POCKET INFECTION. ANTIBIOTIC TREATMENT WAS ADMINISTERED. A NEW CRT-D SYSTEM WAS IMPLANTED FIVE DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12583875 ↗
• InjuryAug 17, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS POSSIBLE EARLY BATTERY DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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 12331441 ↗
• InjuryJul 2, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. HIGH PACING THRESHOLDS WERE ALSO NOTED ON THE LEFT VENTRICULAR (LV) LEAD. THE CRT-D WAS EXPLANTED AND REPLACED AND THE LEAD 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 12106138 ↗
• InjuryJun 15, 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 12005400 ↗
• InjuryMay 18, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION AND WAS NOTED TO HAVE REACHED RECOMMENDED REPLACEMENT TIME (RRT) UNEXPECTEDLY. 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 11841438 ↗
• InjuryApr 28, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO AN ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE VERSES VENTRICULAR FIBRILLATION (VF). THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 11738540 ↗
• InjuryMar 5, 2021Misconnection; Misconnection

  IT WAS REPORTED THAT DURING A REPLACEMENT PROCEDURE FOR A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WHICH EXHIBITED NORMAL BATTERY DEPLETION, IT WAS VERY DIFFICULT TO REMOVE THE RIGHT VENTRICULAR (RV) LEAD FROM THE DEVICE HEADER. THE RV LEAD WAS UNSCREWED BUT COULD NOT BE REMOVED FROM THE HEADER UNTIL A LARGE BORE NEEDLE WAS USED THROUGH THE BACK OF THE DEVICE HEADER. THE LEAD WAS TESTED THROUGH AN ANALYZER AND ALL MEASUREMENTS WERE WITHIN NORMAL RANGE. THE CRTD WAS EXPLANTED AND REPLACED AND THE RV LEAD WAS CONNECTED TO THE NEW CRT-D WITH STABLE MEASUREMENTS. THE RV LEAD 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 11422225 ↗
• InjuryFeb 17, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE CLINICIAN NOTED THAT THE SHOCKS PROVIDED WERE FELT TO BE APPROPRIATE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 11337761 ↗
• MalfunctionDec 28, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) "IS NOT WORKING." 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 11077182 ↗
• MalfunctionNov 25, 2020Communication or Transmission Problem; Missing Test Results; Communication or Transmission Problem; Missing Test Results

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO PROVIDE A VALID BATTERY VOLTAGE MEASUREMENT. IT WAS SUSPECTED TO BE DUE TO INTERMITTENT TELEMETRY DURING A REMOTE TRANSMISSION. 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 10906284 ↗
• InjuryNov 11, 2020Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED HIGH VOLTAGE THERAPY FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE DURING AN ATRIAL ARRHYTHMIA. 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: Shock from Patient Lead(s)

  MAUDE report 10825547 ↗
• MalfunctionOct 5, 2020Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED FOR OVERSENSING OF NOISE DUE TO EXTERNAL ELECTROMAGNETIC INTERFERENCE. IT WAS NOTED THAT THE PATIENT HAD BEEN USING A CHAINSAW AT THE TIME OF THE ALERT. THE DEVICE 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 10627616 ↗