Viva™ S CRT-D DTBB1D4 (UDI 00643169720268)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169720268), received between Jan 29, 2020 and Jul 7, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (2 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-1742-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED, THAT THE PATIENT RECEIVED A POTENTIALLY INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. WHICH WAS DETECTED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), AS VENTRICULAR TACHYCARDIA (VT). 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 17283261 ↗
• InjuryJun 9, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE SHOCKS FOR POSSIBLY ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS FAST VENTRICULAR TACHYCARDIA (VT). 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 14645492 ↗
• MalfunctionJan 21, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE GETTING LIGHTHEADED AND DIZZY AND NOTED THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING PROPERLY. THE PATIENT NOTED THAT PREVIOUSLY THEY WERE SEEN AND IT WAS "NOT WORKING RIGHT AND THEY WERE GOING TO REPLACE THE DEVICE BUT THEN IT STARTED WORKING." THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 13315540 ↗
• MalfunctionJul 16, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT OF FEELING SOME PAIN NEAR THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT SITE. PATIENT NOTED THAT IT'S NOT CHEST PAIN LIKE A HEART ATTACK, BUT MORE LIKE THE PATIENT BUMPED INTO SOMETHING AND THE DEVICE MAY HAVE MOVED AROUND A LITTLE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 12181104 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROPHYLACTIC DEVICE REVISION PROCEDURE, WHILE FREEING THE LEADS A PORTION OF THE LEFT VENTRICULAR (LV) LEAD WAS ACCIDENTALLY TRANSECTED FULLY CUT OFF, AND THE PORTION WAS REMOVED FROM THE BODY. THE LV LEAD IS NON FUNCTIONING, TURNED OFF AND REMAINS IN THE PATIENT. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD THRESHOLDS ARE CHRONICALLY HIGH AND VARIABLE. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 10864708 ↗
• MalfunctionAug 3, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A PACING RATE LOWER THAN THE PROGRAMMED LOWER RATE. IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) FOLLOWING VENTRICULAR AND BI-VENTRICULAR PACING EVENTS. THE CRT-D AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10356173 ↗
• MalfunctionJan 29, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT A PRE-OPERATIVE INTERROGATION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) YIELDED A BATTERY LONGEVITY ESTIMATION THAT DID NOT MEET INDICATION FOR IMPLANT. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9644464 ↗