BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1851589 · Received September 23, 2010

    Report

    Report Number
    1851589
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 23, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    BILATERAL DEEP BRAIN STIMULATOR (DBS) LEADS BECAME DISCONNECTED AND WERE REPLACED. THEY WERE DISCARDED PER PROTOCOL. DBS INTERNAL PULSE GENERATOR REMOVED AND REPLACED AT SURGEON REQUEST DUE TO SUSPECTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION * NKG701620H

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR