BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY STEERABLE

    MDR report key: 3092823 · Received May 3, 2013

    Report

    Report Number
    2124215-2013-04980
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526419324
    PMA / PMN Number
    P050046/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195775 ACUITY STEERABLE PERMANENT DEFIBRILLATOR ELECTRODES NVY BOSTON SCIENTIFIC CORPORATION 4554 191067 00802526419324

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Life Threatening| H| R