Viva™ S CRT-D DTBB1D4 (UDI 00643169929388)Recalls & reported problems
Medtronic, Inc. · CRT-D DTBB1D4 VIVA S US DF4 · Class 3 · Implant
All models of Viva S CRT-D (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169929388), received between Apr 25, 2018 and Nov 2, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Failure to Capture” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Failure to Capture1
- High impedance1
- Loose or Intermittent Connection1
- Mechanical Problem1
- Misconnection1
- Pacing Problem1
Patient problems
- Asystole1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 2, 2023Failure to Capture; Loose or Intermittent Connection; Misconnection; Pacing Problem; Failure to Capture; Loose or Intermittent Connection; Misconnection; Pacing Problem
IT WAS REPORTED THAT PATIENT WAS NOTED TO HAVE EXPERIENCED ASYSTOLE. DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) A PACING PROBLEM, LOSS OF CAPTURE OCCURRED WITH PROBABLE CONNECTOR, HEADER ISSUE. THE CRT-D WAS EXPLANTED AND REPLACED THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACER SPIKES, LOSS OF CAPTURE, INTERMITTENT CAPTURE AND A DISLODGE CONFIRMED. THE RV LEAD WAS RE-POSITIONED AND REMAINS IN USE. THE RIGHT ATRIAL (RA) LEAD NOTED WITH PACER SPIKES, LOSS OF CAPTURE. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Asystole
MAUDE report 18059752 ↗InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THE PATIENT WAS ALSO IMPLANTED WITH AN ABSORBABLE ENVELOPE.
Patient problems: Unspecified Infection
MAUDE report 7651410 ↗InjuryApr 25, 2018High impedance; Mechanical Problem; High impedance; Mechanical Problem
IT WAS LATER REPORTED THAT THERE WAS A DEVICE HEADER ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7462730 ↗
Other Programmer, pacemaker devices
- Viva™ XT CRT-D DTBA1D1Medtronic, Inc. · Programmer, pacemaker1 recall25 deaths893 reports
- Medtronic CareLink® Programmer 2090WMedtronic, Inc. · Programmer, pacemaker3 recalls489 reports
- Medtronic CareLink® Programmer 2090WMedtronic, Inc. · Programmer, pacemaker3 recalls208 reports
- Viva™ Quad XT CRT-D DTBA1Q1Medtronic, Inc. · Programmer, pacemaker2 recalls6 deaths236 reports
- Medtronic CareLink® Programmer 2090Medtronic, Inc. · Programmer, pacemaker2 recalls198 reports
- Medtronic CareLink® Programmer 2090Medtronic, Inc. · Programmer, pacemaker3 recalls108 reports
- Viva™ Quad S CRT-D DTBB1QQMedtronic, Inc. · Programmer, pacemaker2 recalls1 death38 reports
- Viva™ Quad XT CRT-D DTBA1QQMedtronic, Inc. · Programmer, pacemaker1 recall47 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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