Viva™ Quad XT CRT-D DTBA1Q1 (UDI 00643169929319)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169929319), received between Feb 8, 2018 and Apr 21, 2025 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE EXPLANT AND REPLACEMENT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE NEW DEVICE WAS RELOCATED MEDIALLY DUE TO DEVICE IRRITATION FROM THE OLD DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21874077 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. A NEW CRT-D SYSTEM WAS IMPLANTED EIGHT DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17686478 ↗
• MalfunctionOct 25, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEART RATE IN THE FORTY BEATS PER MINUTE RANGE. A DEVICE INTERROGATION NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMED TO PACE AT A LOWER RATE OF FIFTY BEATS PER MINUTE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 15669498 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN 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 11019255 ↗
• InjuryDec 3, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT HAD A "FALL AND IT DISLODGED A WIRE AND WAS USING UP MORE BATTERY THAN USUAL". A DEVICE CHECK HAS BEEN PERFORMED LAST WEEK BUT WANTED TO CONFIRM BATTERY STATUS. THE LEAD AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall

  MAUDE report 10942143 ↗
• InjuryApr 28, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER THEY WERE WALKING AND FELT SHOCKS FROM THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE CLINICIAN NOTED THE PATIENT HAD BEEN FEELING LIGHTHEADED FOR A FEW DAYS AND WAS SYMPTOMATIC TO ANTI-TACHYCARDIA PACING (ATP). IT WAS ADDED THE PATIENT HAD RECEIVED MULTIPLE SHOCKS AND SUSPECTED THE THERAPY MAY HAVE BEEN INAPPROPRIATELY DELIVERED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) RATHER THAN VENTRICULAR TACHYCARDIA (VT). THE DEVICE REMAINS IN USE AT THIS TIME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 10006631 ↗
• InjuryMar 7, 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. THE DEVICE AND LEADS WERE EXPLANTED AND LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8401305 ↗
• MalfunctionMar 1, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT UPON DEVICE INTERROGATION, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY VOLTAGE WAS BELOW INDICATION FOR IMPLANT. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8383473 ↗
• MalfunctionFeb 22, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE DEVICE WAS INTERROGATED AND THE BATTERY VOLTAGE WAS BELOW THE LEVEL INDICATED FOR IMPLANT. DURING THE PROCEDURE, THE BATTERY VOLTAGE WAS STILL BELOW THE LEVEL INDICATED FOR IMPLANT AFTER THE DEVICE WAS AT ROOM TEMPERATURE. THE DEVICE WAS NOT USED AND A DIFFERENT 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 8363552 ↗
• InjuryJan 11, 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 EXTRACTED DUE TO A POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8242251 ↗
• MalfunctionOct 10, 2018Failure to Capture; Mechanical Problem; Misconnection; Failure to Capture; Mechanical Problem; Misconnection

  IT WAS REPORTED THAT THERE WAS A HEADER ISSUE WITH THE ATTEMPTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS PACING CAPTURE COULD NOT BE DEMONSTRATED THROUGH THE ATRIAL PORT. AFTER ATTEMPTS TO REPROGRAM AND TROUBLESHOOT, A DIFFERENT 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 7954442 ↗
• InjuryJun 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR POSSIBLE INFECTION. BLOOD CULTURES TAKEN WERE POSITIVE FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. THE PATIENT DEVELOPED SEPSIS AND WAS GIVEN ANTIBIOTICS. THE DEVICE AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 7583427 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S 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 7534691 ↗
• MalfunctionApr 10, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT WHEN A MEDICAL EQUIPMENT COMPANY REPRESENTATIVE INTERROGATED THE DEVICE PRIOR TO USE, IT WAS NOTICED TO HAVE A GRAY BATTERY LONGEVITY STATUS BAR. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7417165 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING POST-OPERATIVE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INCISION CHECK, ¿AN OPEN AREA¿ WAS FOUND TO BE MID-INCISION AND CHARACTERIZED AS SUPERFICIAL WITHOUT REDNESS OR DRAINAGE. STERISTRIPS WAS APPLIED AND THE DEVICE REMAIN IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Impaired Healing

  MAUDE report 7254891 ↗