Viva™ S CRT-D DTBB1D4 (UDI 00643169007178)Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00643169007178), received between Feb 10, 2015 and May 17, 2024 — classified as 51 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (23 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 64 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryApr 4, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED 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 13995149 ↗
• InjuryJan 12, 2022Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS CONCERNED ABOUT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMING AFTER RECEIVED AN APPROPRIATE SHOCK. THE PATIENT NOTED THAT THEY HAD FELT DIFFERENT BEFORE THE SHOCK. THE CRT-D WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13237146 ↗
• InjuryJan 5, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS ALSO REPORTED BY THE PATIENT THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED HIGH VOLTAGE SHOCK THERAPY. IT WAS DISCLOSED BY THE CLINIC THAT SHOCK WAS INAPPROPRIATE THERAPY AS IT OCCURRED DURING EPISODE OF ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. ADJUSTMENT WAS MADE TO MEDICATION TREATMENT. NO ACTION WAS TAKEN WITH THE DEVICE. 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 13172233 ↗
• MalfunctionNov 12, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE DELIVERED INAPPROPRIATE PACING. 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 12803797 ↗
• InjurySep 10, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED SHORTER THAN EXPECTED LONGEVITY ESTIMATE DUE TO A PROGRAMMER SOFTWARE ESTIMATOR ERROR. IT WAS ALSO REPORTED THE CRT-D EXHIBITED PREMATURE BATTERY DEPLETION. THE PROGRAMMER REMAINS IN USE. 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 12453085 ↗
• InjuryJun 8, 2021Adverse 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) POCKET HAD ERODED OVER TIME WITH THE PATIENT'S WEIGHT LOSS BEING A CONTRIBUTING FACTOR. THE SYSTEM WAS REMOVED AND A NEW SYSTEM WAS IMPLANTED ON THE PATIENT'S OPPOSITE SIDE APPROXIMATELY TWO WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 11957863 ↗
• InjuryMay 4, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS LATER REPORTED THAT THERE WERE NO KNOWN PRODUCT PERFORMANCE ISSUES THAT MAY HAVE CONTRIBUTED TO THE PATIENT PASSING OUT.

  Patient problems: Syncope/Fainting

  MAUDE report 11773016 ↗
• MalfunctionMay 4, 2021Battery Problem; Battery Problem

  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPLACED DUE TO REACHING RECOMMENDED REPLACEMENT TIME (RRT). THE CRT-D WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT-OF-SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OFTHIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768821 ↗
• MalfunctionJan 28, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A REPLACEMENT PROCEDURE THE SET SCREW FELL OUT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE LEAD COULD NOT BE REMOVED FROM THE HEADER. A SECOND SCREW WAS FOUND AND WHEN THE SECOND SCREW FELL OUT, THE LEAD WAS SUCCESSFULLY REMOVED. THE CRT-D WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11243207 ↗
• InjuryJan 22, 2021Adverse 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 11214705 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET EROSION WITH POSSIBLE INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND A NEW SYSTEM WAS IMPLANTED A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10885136 ↗
• InjuryOct 2, 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 AN (B)(6) INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10619451 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RE-SYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A SYSTEMIC INFECTION. A NEW CARDIAC RE-SYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS IMPLANTED SIX DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE ORGANISM WAS IDENTIFIED TO BE METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS BACTEREMIA AND RIGHT VENTRICULAR (RV) LEAD VEGETATION WAS NOTED.

  Patient problems: Unspecified Infection

  MAUDE report 10420485 ↗
• InjuryMay 18, 2020Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A RADIATION TREATMENT THAT FAR EXCEEDED THE RECOMMENDED DOSE OF RADIATION, CAUSING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TO FUNCTION INAPPROPRIATELY. ABNORMAL ELECTROGRAMS DEMONSTRATED NO SENSING OF RHYTHM. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10065982 ↗
• InjuryApr 2, 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 BECAUSE THE SYSTEM WAS BLOCKING A VEIN WHICH THEN LEAD TO THE PATIENT'S ARM SWELLING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Occlusion; Swelling

  MAUDE report 9917822 ↗
• InjuryFeb 10, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED HIGH VOLTAGE THERAPY FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. 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 9689065 ↗
• InjuryJan 28, 2020Premature 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 Known Impact Or Consequence To Patient

  MAUDE report 9636477 ↗
• InjuryDec 3, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT (LIA) ON THE RIGHT VENTRICULAR (RV) LEAD FOR HIGH RATE NON-SUSTAINED EPISODES AND ELEVATED SHORT VENTRICULAR INTERVALS. THERE WAS ALSO A NOISE WARNING, OVERSENSING, AND LOW PACING IMPEDANCE ON THE RV LEAD, WHICH WAS NOTED TO BE FRACTURED. THE PATIENT WAS INAPPROPRIATELY SHOCKED DUE TO THE RV LEAD ISSUE. THE THERAPY PORTION OF THE RV LEAD WAS PROGRAMMED OFF. IT WAS NOTED THAT THIS LEAD TO PREMATURE BATTERY DEPLETION ON THE DEVICE. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9405025 ↗
• InjuryOct 16, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED RAPID BATTERY DEPLETION. THE CRT-D WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9200372 ↗
• InjuryOct 16, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE VALUES AND OVERSENSING DUE TO FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9199722 ↗
• InjurySep 27, 2019Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERAPY WAS INAPPROPRIATELY WITHHELD FOR AN EPISODE OF VENTRICULAR TACHYCARDIA (VT). 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: No Code Available

  MAUDE report 9129427 ↗
• InjuryJul 15, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8790014 ↗
• InjuryMay 23, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED ONE SHOCK FOR AN EPISODE IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT HAD AN ATRIAL ARRHYTHMIA IN-PROGRESS AT THE TIME OF THERAPY. THERE WAS SUSPECTED THERAPY FOR RAPID VENTRICULAR RATE DURING AN ATRIAL ARRHYTHMIA. 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 8635002 ↗