Viva S CRT-DRecalls & reported problems across all models

We found 8 models of Viva S CRT-D by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 397 adverse event reports in the FDA's MAUDE database, received between Dec 10, 2013 and Sep 15, 2025 — classified as 11 deaths, 299 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (128 reports).

4 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Viva S CRT-D recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 10, 2023Open, 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 ↗

2. May 10, 2023Open, 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-1741-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Feb 3, 2021Open, 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 · names 4 of these models · Recall details · FDA record ↗

4. Dec 19, 2017Terminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0584-2018 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗

Most reported Viva S CRT-D problems

Viva S CRT-D models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Viva™ S CRT-D DTBB1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls8 deaths227 reports
• Viva™ S CRT-D DTBB1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls64 reports
• Viva™ S CRT-D DTBB1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall3 deaths67 reports
• Viva™ S CRT-D DTBB1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall12 reports
• Viva™ S CRT-D DTBB1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall8 reports
• Viva™ S CRT-D DTBB1D4

  Programmer, pacemaker
  1 recall7 reports
• Viva™ S CRT-D DTBB1D1

  Programmer, pacemaker
  9 reports
• Viva™ S CRT-D DTBB1D4

  Programmer, pacemaker
  3 reports

Recent Viva S CRT-D adverse event reports

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

• InjurySep 15, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DEVICE DATA TRANSMITTED FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR ( CRT-D) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. THE CRT-D 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 23057642 ↗
• InjuryJul 14, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE AN ATRIAL ARRHYTHMIA WITH FAST VENTRICULAR RATES. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 22498392 ↗
• InjuryApr 21, 2025Adverse 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) AND LEADS WERE EXPLANTED. THE DEVICE WAS CONNECTED TO A TEMPORARY PACING WIRE AND IS BEING USED AS A TEMPORARY PACEMAKER UNTIL THE SYSTEM IS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21877163 ↗
• InjuryFeb 3, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE SYNCOPE WHEN THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED END OF SERVICE (EOS). THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 21292938 ↗
• InjuryJan 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THE DEVICE FAILED ON THEM. 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 21147103 ↗
• InjurySep 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO BE SEPTIC DURING A PHYSICAL EXAM. THE PATIENT DEVELOPED BACTEREMIA, FEVER AND VEGETATION WAS GROWING ON THE LEADS. THE CRT-D SYSTEM WAS EXPLANTED. THE ORGANISM WAS IDENTIFIED AS BETA HEMOLYTIC STREPTOCOCCUS. APPROXIMATELY TWELVE DAYS LATER, A REPLACEMENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Fever; Sepsis

  MAUDE report 20276067 ↗
• MalfunctionAug 9, 2024Failure to Interrogate; Insufficient Device Problem Information; Failure to Interrogate; Insufficient Device Problem Information

  IT WAS FURTHER REPORTED VIA FOLLOW-UP WITH THE CLINIC THAT THE PATIENT WAS BRADYCARDIC. THE CRTD HAD DEPLETED AND COULD NOT BE INTERROGATED.

  Patient problems: Bradycardia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955320 ↗
• 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 ↗
• InjuryJun 1, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED, BY THE PATIENT, THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED. AND REPLACED, BECAUSE OF SHORTER BATTERY LIFE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441962 ↗
• InjuryMay 17, 2024Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS NOT WORKED IN TWO YEARS AND THE BATTERY IS DEAD. THE 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 19342093 ↗
• MalfunctionApr 23, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI)/RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166789 ↗
• InjuryFeb 5, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEFIBRILLATION WAS PROGRAMMED OFF BECAUSE THE DEVICE WAS "GOING OFF INAPPROPRIATELY". THE CRT-D REMAINS IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18641773 ↗
• InjuryJan 30, 2024Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT BOTH THE ATRIAL AND RIGHT VENTRICULAR (RV) LEADS HAD VEGETATION. THE DEVICE, THE ATRIAL, RV AND LEFT VENTRICULAR (LV) LEADS WERE EXPLANTED AND REPLACED ONE WEEK LATER DUE TO THE ENDOCARDITIS INFECTION.

  Patient problems: Bradycardia; Endocarditis; Heart Failure/Congestive Heart Failure; Sepsis

  MAUDE report 18607718 ↗
• MalfunctionNov 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. THE CLINICIAN SUSPECTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 18212437 ↗
• 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 ↗

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