BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3071470 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-03661
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    UDI-DI
    00802526397738
    PMA / PMN Number
    P960006/S005
    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
    173200 FLEXTEND PERMANENT PACEMAKER ELECTRODE DTB BOSTON SCIENTIFIC CORPORATION 4087 00802526397738

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Life Threatening| R| H