Viva™ S CRT-D DTBB1D1 (UDI 00643169530188)Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00643169530188), received between Dec 9, 2016 and Feb 3, 2025 — classified as 3 deaths, 49 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (16 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. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryOct 23, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A PREMATURE BATTERY DEPLETION.  IT WAS NOTED THAT THE HIS BUNDLE LEAD HAD HIGHER OUTPUTS.  THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEAD 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 17989792 ↗
• InjuryJul 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PATIENT REPORTED HAVING PACEMAKER ISSUE AND LIGHTHEADEDNESS.  THE CRT-D WAS SUBSEQUENTLY EXPLANTED AND REPLACED APPROXIMATELY THREE WEEKS LATER.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 17389921 ↗
• InjuryJul 18, 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 POSSIBLY EXPLANTED AND REPLACED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17341224 ↗
• InjuryJun 19, 2023Premature 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 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 17159610 ↗
• InjuryJun 5, 2023Premature Discharge of Battery; Failure to Interrogate; Inappropriate or Unexpected Reset; Premature Discharge of Battery; Failure to Interrogate; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A PARTIAL RESET, THE CRT-D WOULD NOT INTERROGATE, AND NO TELEMETRY WITH THE CRT-D WAS POSSIBLE. ADDITIONALLY, THERE WAS SUSPECTED RAPID 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 17065618 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED 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 17003858 ↗
• InjuryMar 22, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A BATTERY ISSUE AND THE DEVICE "SLIPPED". 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 16592120 ↗
• InjuryJan 25, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT'S DEVICE AND LEADS HAD MIGRATED DOWN APPROXIMATELY 15 CM CAUDALLY FROM THE ORIGINAL INSERTION SITE. THE LEADS WERE NOTED TO BE COILED ON TOP OF THE DEVICE. THE LEADS WERE FREED AT THE INSERTION SITE AND A NEW POCKET WAS CREATED. A SECOND INCISION WAS MADE ALLOWING THE CAN TO BE REMOVED AND LEADS DISCONNECTED. THE LEADS WERE TUNNELED TO THE NEW POCKET. DURING TESTING IT WAS REVEALED THAT THE LEFT VENTRICULAR (LV) LEAD WAS NOT CAPTURING. THE LEAD WAS CAPPED. 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 16242010 ↗
• InjuryJul 25, 2022Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)  MAY HAVE INAPPROPRIATELY WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT) THAT WAS DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 15094655 ↗
• InjuryJul 14, 2022Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 15018323 ↗
• InjuryJun 23, 2022Electromagnetic Interference; Over-Sensing; Pacing Problem; Device Sensing Problem; Electromagnetic Interference; Over-Sensing; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING CAUSED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TO DETECT AN EPISODE OF VENTRICULAR FIBRILLATION (VF). THE PATIENT WAS NOTED TO BE USING A WATER PUMP TO FILL A SWIMMING POOL AT THE TIME. THE PATIENT LOST CONSCIOUSNESS AND FELL INTO THE POOL AS THE OVERSENSING RESULTED IN A LOSS OF PACING SUPPORT FOR APPROXIMATELY TEN SECONDS. PACING SUPPORT RESUMED AND THE DEVICE RETURNED TO NORMAL FUNCTION ONCE EXPOSURE TO THE EMI CEASED. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 14792696 ↗
• MalfunctionDec 1, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THE PATIENT REPORTED FEELING A LITTLE SHOCKING ABOVE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE THAT WAS GOING INTO THE SHOULDER. THE PATIENT WAS UNABLE TO SEND A TRANSMISSION FROM THE REMOTE MONITOR. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12909364 ↗
• InjurySep 28, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. 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 12543844 ↗
• InjuryAug 3, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INAPPROPRIATELY WITHHELD VENTRICULAR TACHYCARDIA (VT) THERAPY DUE TO SUPRA VENTRICULAR TACHYCARDIA (SVT) DISCRIMINATOR. ATRIAL FIBRILLATION WAS CLASSIFIED THREE TIMES FOR TRUE VT. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 12270265 ↗
• InjuryJul 27, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12232806 ↗
• InjuryApr 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 AN INFECTION WITH SKIN EROSION SEVERAL YEARS AFTER IMPLANT. CULTURES WERE TAKEN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 11711468 ↗
• InjuryMar 18, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. 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 11521008 ↗
• InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED POCKET WITH PURULENT DRAINAGE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11383142 ↗
• InjuryNov 26, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING USE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO THE PERFORMANCE OF AN ASSOCIATED LEAD. THE CRT-D WAS EXPLANTED AND REPLACED. A NEW CRT-D WAS PLACED IN THE POCKET, THE POCKET WAS FLUSHED WITH ANTIBIOTIC SOLUTION, AND A ANTIBIOTIC POUCH WAS USED. THE LV EPICARDIAL LEAD, THE CHRONIC RIGHT VENTRICULAR (RV) LEAD AND THE CHRONIC RIGHT ATRIAL (RA) LEAD WERE CONNECTED TO THE NEW DEVICE, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10911138 ↗
• InjuryNov 20, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD ON THE LEFT VENTRICULAR (LV) LEAD THAT CAUSED A SHORT BATTERY LIFE ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LEAD WAS CAPPED AND REPLACED AND 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 10873122 ↗
• MalfunctionOct 13, 2020Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR HIGH RATE NON-SUSTAINED EPISODES AND A HIGH NUMBER OF SHORT V-V INTERVALS DUE TO ELECTROMAGNETIC INTERFERENCE ON THE DEVICE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10670841 ↗
• MalfunctionOct 2, 2020Battery Problem; Battery Problem

  THE DEVICE WAS REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). 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 Consequences Or Impact To Patient

  MAUDE report 10623043 ↗