Viva™ S CRT-D DTBB1D1 (UDI 00643169720329)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169720329), received between Aug 22, 2018 and Aug 8, 2023 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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. May 10, 2023Class IOpen, 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 ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2023Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 17481556 ↗
• MalfunctionAug 10, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE DISPLAYED A SHORT CIRCUIT PROTECTION THAT WAS TRIGGERED DURING HIGH VOLTAGE THERAPY, AND LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY WAS DELIVERED. IT WAS NOTED THAT THIS OCCURRED DURING THEIMPLANT PROCEDURE AT DEFIBRILLATION THRESHOLD TESTING AFTER THE DEVICE DELIVERED SEVERAL APPROPRIATE, AND FULL ENERGY SHOCKS, WHICH FAILED. A MANUAL DEFIBRILLATION FROM THE DEVICE WAS DELIVERED AND THE RHYTHM WAS SUCCESSFULLY TERMINATED DESPITE DELIVERING LESS THAN PROGRAMMED ENERGY. IT WAS ALSO REPORTED THAT RIGHT VENTRICULAR (RV) DEFIBRILLATION AND SUPERIOR VENA CAVA (SVC) IMPEDANCE MEASUREMENTS WERE LOW. THE DEVICE AND LEADS 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 15201074 ↗
• InjuryAug 16, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT HIGH RIGHT VENTRICULAR (RV) LEAD THRESHOLDS LED TO PREMATURE BATTERY DEPLETION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED, AND THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329256 ↗
• InjuryAug 10, 2021Premature Discharge of Battery; Failure to Charge; Delayed Charge Time; Premature Discharge of Battery; Failure to Charge; Delayed Charge Time

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ALERTED FOR A CHARGE CIRCUIT TIMEOUT. IT WAS ALSO NOTED THAT THE DEVICE HAD AN ABNORMAL AND SIGNIFICANT DECREASE IN BATTERY VOLTAGE. 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 12300383 ↗
• MalfunctionMar 18, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A BATTERY VOLTAGE THAT DID NOT MEET INDICATIONS FOR IMPLANT. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9849701 ↗
• MalfunctionFeb 18, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE DEVICE WAS INTERROGATED AND THE BATTERY VOLTAGE WAS BELOW THE LEVEL INDICATED FOR IMPLANT. THE BATTERY VOLTAGE WAS STILL BELOW THE LEVEL INDICATED FOR IMPLANT AFTER THE DEVICE WAS AT ROOM TEMPERATURE FOR OVER A WEEK. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9721251 ↗
• InjuryDec 20, 2019Adverse 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 INFECTION. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS THEN IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9504609 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE AND LEADS WERE EXPLANTED DUE TO INFECTION. CULTURES WERE TAKEN AND ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9411416 ↗
• InjuryOct 3, 2019Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH AND THEY "FEEL WORSE" WITH THEIR NEW CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS DETERMINED THAT THE PATIENT'S HEART RATE WAS BELOW THE CRT-D'S PROGRAMMED LOWER RATE. THE CRT-D WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 9150529 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A WOUND CHECK VISIT THE PATIENT WAS NOTED TO HAVE A FEVER AND THE INCISION LINE WAS DESCRIBED AS BEING "DARK/PURPLE AT THE CENTER OF THE INCISION." THE PATIENT WAS STARTED ON ANTIBIOTIC MEDICATION. AT A FOLLOW UP VISIT A DIME SIZED SCAB WAS NOTED AND THE PATIENT HAD A FEVER. THE PATIENT NOTED AFTER THE INITIAL WOUND CHECK VISIT, THE INCISION HAD "BURST OPEN" IN ONE SPOT AND SCABBED AFTERWARDS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ANTIBIOTICS AND A WOUND REVISION, AFTER WHICH, NO FURTHER FEVER WAS NOTED AND CULTURES WERE NEGATIVE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 8382223 ↗
• InjuryOct 31, 2018Adverse 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8026742 ↗
• MalfunctionAug 22, 2018High impedance; Misconnection; High impedance; Misconnection

  IT WAS REPORTED THAT AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CHANGE OUT PROCEDURE WHEN THE EXISTING RIGHT VENTRICULAR (RV) LEAD WAS ATTACHED TO THE REPLACEMENT CRT-D THE RV DEFIBRILLATOR IMPEDANCE WAS HIGH AND UNDEFINED. THE RV LEAD WAS REMOVED AND THEN REATTACHED WITH THE SAME RESULTS. ADDITIONALLY, THE RV AND SVC (SUPERIOR VENA CAVA) COILS WERE SWAPPED AND THE RESULTS IN THE RV COIL HEADER WAS STILL HIGH AND UNDEFINED IMPEDANCE. A NEW CRT-D WAS THEN GIVEN TO THE PHYSICIAN AND IT TESTED FINE. THE REPLACEMENT CRT-D WAS NOT USED AND THE NEW CRT-D WAS IMPLANTED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7806896 ↗