Viva™ S CRT-D DTBB1D1 (UDI 00643169007185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 227 adverse event reports that list this exact device (DI 00643169007185), received between Dec 10, 2013 and Sep 15, 2025 — classified as 8 deaths, 172 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (83 reports).

2 FDA recall records 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 ↗

2. Dec 19, 2017Class ITerminated

   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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 227 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryAug 14, 2023High impedance; Loose or Intermittent Connection; Misconnection; High impedance; Loose or Intermittent Connection; Misconnection

  IT WAS FURTHER REPORTED THAT THE CRT-D WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541799 ↗
• InjuryApr 3, 2023Adverse 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 INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pneumonia; Unspecified Infection

  MAUDE report 16670633 ↗
• InjuryJan 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE DEVICE SITE DUE TO THE DEVICE PROTRUDING AS A RESULT OF THE PATIENT'S WEIGHT LOSS. THERE WAS NO ERYTHEMA OR SHININESS CONSISTENT WITH SKIN BREAKDOWN. IT WAS NOTED THE PHYSICIAN ELECTED TO REPLACE THE DEVICE DUE TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHING ELECTIVE REPLACEMENT INDICATOR (ERI). THE CRT-D WAS EXPLANTED AND REPLACED SUBPECTORAL TO REDUCE THE DISCOMFORT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16261567 ↗
• MalfunctionJan 23, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) LONGEVITY ESTIMATE HAD FALLEN BY FOURTEEN MONTHS WITHIN A MONTH. IN ADDITION, THERE WAS AN INCREASE IN RIGHT VENTRICULAR (RV) LEAD CAPTURE THRESHOLDS, WITH HIGH RV THRESHOLDS OBSERVED ON THE RV LEAD TRENDS, THAT CORRESPONDED WITH A DROP IN R WAVE AMPLITUDE. THE CRT-D AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223210 ↗
• DeathDec 1, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT WHILE THE PATIENT WAS IN VENTRICULAR TACHYCARDIA (VT), THERAPY WAS WITHHELD FOUR TIMES DUE TO LOW RIGHT VENTRICULAR (RV) LEAD DEFIBRILLATION IMPEDANCE. ON THE FIFTH ATTEMPT A SHOCK WAS SUCCESSFULLY DELIVERED AND THE PATIENT'S VT WAS CONVERTED. FOLLOW UP DETERMINED THAT PATIENT LATER PASSED AWAY. THE PATIENT'S CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. IT WAS FURTHER REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE INDICATED THAT SHORT CIRCUIT PROTECTION WAS TRIGGERED DURING HIGH VOLTAGE THERAPY AND LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY WAS DELIVERED. IT WAS CLARIFIED THAT NO SHOCKS WERE WITHHELD DURING THE VT EPISODE.

  Patient problems: Tachycardia

  MAUDE report 15893994 ↗
• MalfunctionOct 21, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED THAT SHORT CIRCUIT PROTECTION OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY. THE DEVICE REMAINS IN USE. THIS INCIDENT WAS NOT REPORTED BY A HEALTH CARE PROVIDER; THEREFORE, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651124 ↗
• InjuryOct 21, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED THAT SHORT CIRCUIT PROTECTION OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY. THE DEVICE WAS EXPLANTED AND REPLACED. THIS INCIDENT WAS NOT REPORTED BY A HEALTH CARE PROVIDER; THEREFORE, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649860 ↗
• MalfunctionSep 6, 2022Battery Problem; Battery Problem

  THE DEVICE WAS RETURNED FROM A MEDICAL EXAMINER AFTER THE PATIENTS DEATH. THE DEVICE WAS ANALYZED AND TESTED OUT OF SPECIFICATION. ADDITIONAL INFORMATION INDICATED THE DEATH WAS UNRELATED TO THE ANALYSIS FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366895 ↗
• InjuryAug 30, 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 REMOVED DUE TO A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 15324416 ↗
• MalfunctionAug 30, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED DIPS IN IMPEDANCE. THE CRT-D AND LV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321533 ↗
• DeathAug 17, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT IS DECEASED. IT WAS ALSO REPORTED THAT THE FAMILY SUSPECTED A POTENTIAL PERFORMANCE ISSUE WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THAT CONTRIBUTED TO THE PATIENT'S DEATH. THE CAUSE OF DEATH WAS NOTED AS SYSTOLIC DIASTOLIC COMBINED HEART FAILURE WITH A PRIMARY CAUSE OF ATRIAL FIBRILLATION (AF) AND SECONDARY CAUSE OF CARDIOMYOPATHY.

  Patient problems: Atrial Fibrillation; Cardiomyopathy

  MAUDE report 15245737 ↗
• MalfunctionAug 17, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE EXPERIENCING LOW ENERGY AT THEIR CABIN AND THEY HAD TO GO HOME BECAUSE THEY WERE NOT FEELING WELL. THE PATIENT FURTHER REPORTED THAT THEIR HEART RATE WAS GOING BELOW THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMED LOWER RATE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fatigue

  MAUDE report 15242773 ↗
• InjuryJul 21, 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 INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15079208 ↗
• InjuryJun 3, 2022Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Decreased Sensitivity; Impedance Problem; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Decreased Sensitivity; Impedance Problem

  IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT (LIA) ON THE RIGHT VENTRICULAR (RV) LEAD FOR HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. A SHOCK WAS ALSO DELIVERED. IT WAS NOTED THAT THERE WAS POSSIBLE RIGHT ATRIAL (RA) LEAD AND RV LEAD OVERSENSING NOTED ON A STORED ELECTROGRAM (EGM) WITH AN INAPPROPRIATE SHOCK. THE LEAD TRENDS SHOWED THE RV LEAD SENSING DECREASED. IT WAS NOTED THAT THIS COINCIDES WITH WHEN THE PATIENT HAD OPEN HEART SURGERY. 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 14593659 ↗
• InjuryMay 18, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY EXHIBITED A POTENTIAL PERFORMANCE ISSUE. 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 14429072 ↗
• InjuryMay 12, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE DEFIBRILLATION THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENT ARTICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED AS VENTRICULAR FIBRILLATION (VF) OR FAST VENTRICULAR TACHYCARDIA (FVT). 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 14379704 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH PERICARDITIS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Inflammation

  MAUDE report 14287350 ↗
• InjuryApr 21, 2022Adverse 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14170237 ↗
• MalfunctionMar 1, 2022Failure to Capture; Device Sensing Problem; Failure to Capture; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), IT WAS NOTED THAT THE DEVICE APPEARED TO BE  SENSING PROPERLY AND NOT CAPTURING.  IT WAS NOTED THAT PACING SPIKES WERE SEEN IN THE MIDDLE OF AN EPISODE ON TELEMETRY.  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 13637144 ↗