Viva™ Quad XT CRT-D DTBA1QQ (UDI 00763000059651)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000059651), received between Apr 10, 2018 and Feb 10, 2026 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Mechanical 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-1733-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED FOR AN UNKNOWN PERFORMANCE PROBLEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Medical device site infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305470 ↗
• MalfunctionJun 13, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT STATED THAT THE DEVICE HAD BEEN TONING EVERYDAY AT PROGRAMMED ALERT TIME FOR MONTHS BUT STOPPED A FEW WEEKS AGO. AT THE CLINIC, THE CRT-D WAS COULD NOT TO BE INTERROGATED WITH THE PROGRAMMER, TRIED MULTIPLE PROGRAMMERS. THE MAGNET OR PROGRAMMER HEAD DID NOT INITIATE A MAGNET TONE. IT WAS NOTED THAT THE CRT-D HAD NOT BEEN CHECKED IN A FEW YEARS.  HE CRT-D 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 17121157 ↗
• InjuryMar 24, 2023Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE SHOCKS FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IN A SHORT PERIOD OF TIME. THE CRT-D TRIGGERED AN CHARGE CIRCUIT TIME OUT DUE TO BEING AT END OF SERVICE (EOS). 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 16612996 ↗
• InjuryDec 1, 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 A POSSIBLE LEAD INFECTION. THE CRT-D SYSTEM WAS SUBSEQUENTLY REPLACED. 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 15896558 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A POCKET INFECTION THAT WAS POSITIVE FOR GRAM POSITIVE RODS FROM AN ASPIRATE PERFORMED. IT WAS ALSO NOTED THAT A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED VEGETATION ON A LEAD. UPON OPENING THE POCKET, A LARGE AMOUNT OF PURULENT PUS WAS EXPRESSED FROM THE POCKET. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Purulent Discharge

  MAUDE report 15115252 ↗
• InjuryJan 25, 2022Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342803 ↗
• MalfunctionSep 27, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO BRADYCARDIA WITH RATES IN THE TWENTIES, WHICH WAS BELOW THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) LOWER RATE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 12532960 ↗
• InjuryApr 4, 2019High impedance; Mechanical Problem; Misconnection; Pacing Problem; High impedance; Mechanical Problem; Misconnection; Pacing Problem

  IT WAS REPORTED THAT POST IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEICE, THERE WAS FAILURE OF PACING AND CAPTURE. INTERROGATION SHOWED THERE WAS INCREASED IMPEDANCE ON THE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS. DURING DEVICE REVISION, THE LEADS WERE DISCONNECTED FROM THE DEVICE AND EVERY LEAD WAS CHECKED ALONE AND ALL LEADS MEASURED NORMALLY. THE SAME DEVICE WAS RECONNECTED TO THE LEADS AND IT WAS FOUND THERE WAS DIFFICULTY CONNECTING LV LEAD TO THE CONNECTOR PORT AND THE SCREW COULD NOT BE FIXED PROPERLY. THERE WAS NO OTHER EXPLANATION FOR THIS PROBLEM EXCEPT TECHNICAL PROBLEM IN THE HEAD CONNECTOR OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED AND ALL PARAMETERS WERE EXCELLENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8482180 ↗
• MalfunctionMar 27, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO IMPLANT WHEN THE REPRESENTATIVE WAS CHECKING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), INTERROGATION DISPLAYED A GRAY BAR INDICATING THE ESTIMATED REMAINING BATTERY VOLTAGE WAS NOT AVAILABLE. THE DEVICE WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8458404 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 8413317 ↗
• MalfunctionMar 4, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE DEVICES WERE INTERROGATED AND THE BATTERY VOLTAGE WAS BELOW THE LEVEL INDICATED FOR IMPLANT. THE BATTERY VOLTAGE WAS STILL BELOW THE LEVEL INDICATED FOR IMPLANT AFTER THE DEVICES WERE LEFT AT ROOM TEMPERATURE. THE DEVICES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8388081 ↗
• InjuryFeb 4, 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. ANTIBIOTIC TREATMENT WAS NECESSARY AND CULTURE SWAB OF THE POCKET WAS SENT TO THE HOSPITAL LAB. 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 8302990 ↗
• MalfunctionApr 25, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN THE PHYSICIAN WENT TO PLACE THE ATRIAL LEAD, THE SETSCREW WOULD NOT ENGAGE THE LEAD AND KEPT TURNING WITHOUT CLAMPING DOWN ON THE LEAD. THE PHYSICIAN ATTEMPTED THIS THREE OR FOUR MORE TIMES PULLING THE WRENCH OUT AND RE-ENGAGING THE GROMMET; BUT IT DID NOT WORK. ANOTHER WRENCH WAS TRIED, BUT THE SETSCREW STILL WOULD NOT RATCHET ON TO THE ATRIAL LEAD. WHEN THE WRENCH WAS PULLED OUT, THE SETSCREW CAME OUT ALSO. AT THAT POINT A NEW DEVICE WAS ATTEMPTED AND IMPLANTED WITH NO ISSUES. ALSO, WHEN PULLING THE RIGHT VENTRICULAR LEAD OUT OF THE FIRST DEVICE, THE SETSCREW CAME OUT WITH THE WRENCH AS WELL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7461894 ↗
• MalfunctionApr 10, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING INITIAL IMPLANT THE SET SCREW WAS INADVERTENTLY REMOVED FROM THE RIGHT VENTRICULAR (RV) PORT ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). DURING REINSERTION OF THE SET SCREW, GROMMET DAMAGE WAS NOTICED. A NEW DEVICE WAS USED AND 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 7418732 ↗
• InjuryApr 10, 2018Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PHYSICIAN PROGRAMMED DOWN/OFF PATIENT¿S RIGHT VENTRICULAR (RV) PACING OUTPUT DUE TO T-WAVE OVERSENSING (TWOS). THE PATIENT WAS SEEN IN THE CLINIC WITH REDUCED % OF BI-VENTRICULAR PACING (LOSS OF CRT PACING). THE DEVICE AND LEAD REMAIN 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 7413678 ↗