BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 21267780 · Received January 29, 2025

    Report

    Report Number
    2124215-2025-04542
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 12, 2025
    Report Date
    January 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    PMA / PMN Number
    P910073/S077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND ONE INAPPROPRIATE SHOCK TO CONVERT ARRHYTHMIA DETECTED IN VENTRICULAR FIBRILLATION (VF) ZONE, WITH A RATE OF 231 BEATS PER MINUTE (BPM). IT APPEARED TO BE A SUPRAVENTRICULAR TACHYCARDIA (SVT) EVENT POSSIBLY PROARRHYTHMIC DUE TO ONSET OF NEW VENTRICULAR ARRHYTHMIA POST-SHOCK. ADDITIONAL INFORMATION PROVIDED ADVISED ADDITIONAL ATP THERAPY DELIVERED TO CONVERT ARRHYTHMIA. ATRIAL LOSS OF CAPTURE (LOC) WAS OBSERVED ON THE PRESENTING ELECTROGRAM (EGM) AND DURING THE TREATED EPISODE. THE ATRIAL OUTPUT IS FIXED AT 2.5V (VOLTS) AT 0.4MS (MILLISECONDS). FURTHER REVIEW WAS RECOMMENDED FOR THE ATRIAL LEAD. AT THIS TIME, THE DEVICE AND LEADS REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PROVIDED ANTI-TACHYCARDIA PACING (ATP) THERAPY TO CONVERT AN ARRHYTHMIA. REVIEW OF THE STORED EPISODES NOTED THE RHYTHM WAS DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) VT-1 ZONES AND ACCELERATED INTO THE VT ZONE. THERAPY WAS NOTED TO BE POTENTIALLY INAPPROPRIATE AS IT APPEARED TO BE A SUPRAVENTRICULAR TACHYCARDIA (SVT) EVENT. ONE ROUND OF ATP WAS DELIVERED THAT REVERTED THE PATIENT'S RHYTHM. LEAD MEASUREMENTS ARE STABLE, AND BATTERY LONGEVITY IS NORMAL. THE ICD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. RECEIVED ADDITIONAL INFORMATION ANTI-TACHYCARDIA PACING (ATP) THERAPY AND VENTRICULAR SHOCK THERAPY WAS DELIVERED TO CONVERT AN ARRHYTHMIA IN MID-JANUARY. THERE WERE THREE EPISODES DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE AT A RATE BETWEEN 219 AND 361 BEATS PER MINUTE (BPM). A TOTAL OF TEN 41J (JOULE) SHOCKS WERE DELIVERED. IT WAS ALSO NOTED THERE WAS NO CLEAR CAPTURE IDENTIFIED DURING THE PACING POST SHOCK THERAPIES ON THIS RIGHT VENTRICULAR (RV) LEAD. REVIEW OF PATIENT STATUS WAS RECOMMENDED. AT THIS TIME, THE DEVICE AND LEAD REMAIN IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830000 ENDOTAK RELIANCE G PERMANENT DEFIBRILLATOR ELECTRODES NVY BOSTON SCIENTIFIC CORPORATION 0295 420537

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown