BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 1083470 · Received July 29, 2008

    Report

    Report Number
    2182207-2008-04486
    Event Type
    Injury
    Date Received
    July 29, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE OVERDISCHARGED THREE TIMES. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE LGW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention