BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC (CAPSUREFIX)

    MDR report key: 250531 · Received November 17, 1999

    Report

    Report Number
    MW1017581
    Event Type
    Injury
    Date Received
    November 17, 1999
    Date of Event
    September 19, 1999
    Report Date
    November 16, 1999
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PACER LEAD WAS FOUND TO BE FRACTURED. DISCOVERED WHEN PACER WAS FOUND TO NOT BE SENSING CORRECTLY ON 9/19/99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC (CAPSUREFIX) Implant VENTRICULAR PACER LEAD DTB MEDTRONIC, INC. 5068-52 *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R