BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 6053809 · Received October 25, 2016

    Report

    Report Number
    6053809
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    August 17, 2016
    Report Date
    August 19, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE LEAD WAS PLACED THROUGH THE LEAD HOLDER THE LEAD BECAME BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704892 MEDTRONIC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 3389S VA18SDN

    Patients

    Seq Age Sex Outcome Treatment
    1 NO| NO OTHER THERAPIES