Viva™ S CRT-D DTBB1D4 (UDI 00643169530195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169530195), received between Jun 8, 2017 and Jun 12, 2024 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MIGRATED DOWN OVER THE YEARS AND IS MOVING UNDER THE PATIENT ARMPIT AND IS UNCOMFORTABLE.  THE DEVICE REMAINS IN USE.  THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522261 ↗
• InjuryApr 7, 2022Premature 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 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 14042105 ↗
• InjuryMar 14, 2022Adverse 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. IT WAS NOTED THAT ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 13763547 ↗
• InjuryAug 9, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON 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 12293955 ↗
• MalfunctionFeb 5, 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 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 11285459 ↗
• InjuryFeb 17, 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 EXPLANTED DUE TO SEPSIS AND THE VEGETATION ON THE LEADS. CULTURES WERE TAKEN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9716973 ↗
• MalfunctionJan 29, 2020Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO HEALTHCARE FACILITY FOR EVALUATION DUE TO COMPLAINTS OF DIAPHRAGMATIC STIMULATION THOUGHT TO BE DUE TO PACING. THE PATIENT SYMPTOMS HAVE BEEN INTERMITTENT FOR APPROXIMATELY SIX AND A HALF MONTHS. THE PATIENT BELIEVES THE DIAPHRAGMATIC STIMULATION IS POSITIONAL, AND IS VERY ANNOYING BUT NOT PAINFUL. UPON INTERROGATION OF THE ASSOCIATED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WITH THE ENCORE PROGRAMMER, INTERROGATION FAILS AT TWENTY PERCENT. MULTIPLE ATTEMPTS TO INTERROGATE THE CRT-D RESULT IN SAME OUTCOME. IT WAS ALSO REPORTED THAT THE PATIENT HAS A NON MEDTRONIC LEFT VENTRICULAR ASSIST DEVICE (LVAD), THAT GIVES OFF ENOUGH ELECTROMAGNETIC INTERFERENCE IT INTERFERES WITH CRT-D - PROGRAMMER COMMUNICATION WHEN USING NON WIRELESS TELEMETRY. TROUBLESHOOTING STEPS WERE ADVISED. IF TROUBLESHOOTING WAS UNSUCCESSFUL THE PATIENT WOULD BE RE-SCHEDULED FOR FOLLOW UP EVALUATION AT A DIFFERENT FACILITY. THE CRT-D, LV LEAD AND ENCORE PROGRAMMER REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9644356 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET REVISION FOR HEMATOMA. DURING THE ICD POCKET REVISION, THE RIGHT VENTRICULAR (RV) LEAD HAD NOISE OVERSENSING DURING ELECTROCAUTERY USE AND DELIVERED UNEXPECTED SHOCK THERAPIES TO THE PATIENT. THE ICD AND RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Shock from Patient Lead(s)

  MAUDE report 6628695 ↗