BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA ICD

    MDR report key: 17350734 · Received July 19, 2023

    Report

    Report Number
    2124215-2023-38120
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    March 13, 2023
    Report Date
    July 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526480782
    PMA / PMN Number
    P960040/S235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING AND SHOCK THERAPY DUE TO POSSIBLE ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (AF W/RVR). THE VENTRICULAR RATE HAD ACCELERATED INTO THE PROGRAMMED VENTRICULAR TACHYCARDIA (VT) ZONE AT 220-222 BEATS/MINUTE. TECHNICAL SERVICES RECOMMENDED FURTHER REVIEW OF DEVICE PROGRAMMING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS ADDITIONALLY REPORTED THAT THERE WAS ANOTHER RECENT EPISODE OF ATP AND SHOCK DELIVERY FOR AF W/RVR IN JUNE. THE VT RATE WAS APPROXIMATELY 210 BEATS/MINUTE. THE ICD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36549 INCEPTA ICD IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC CORPORATION E163 106685 00802526480782

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Unknown Required Intervention