BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC, INC

    MDR report key: 141313 · Received December 17, 1997

    Report

    Report Number
    MW1012721
    Event Type
    Malfunction
    Date Received
    December 17, 1997
    Date of Event
    November 6, 1997
    Report Date
    December 17, 1997
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPLACED VENTRICULAR LEAD: THE THRESHOLDS WERE UNACCEPTABLE. THERE WAS APPARENT FRACTURE AND SENSING DIFFICULTY; OVERSENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC Implant VENTRICULAR LEAD DTB MEDTRONIC INC. 5034-58 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR