BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA I

    MDR report key: 2941569 · Received February 4, 2013

    Report

    Report Number
    2124215-2012-06408
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    April 24, 2012
    Report Date
    April 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    N970003/S016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47497 INSIGNIA I IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION 1298 156895

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Life Threatening