BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1040067 · Received May 7, 2008

    Report

    Report Number
    3004209178-2008-02452
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT'S NEUROSTIMULATOR WAS REMOVED DUE TO POSSIBLE INFECTION. THE DEVICE WAS BEING SENT FOR CULTURE. NO PT SYMPTOMS WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| EXPLANTED| EXTENSION MODEL 3708160| RECHARGER MODEL 37752| IMPLANTED| EXPLANTED| ADAPTOR MODEL 355029| LEAD MODEL 377845| PROGRAMMER MODEL 37742| EXPLANTED| ADAPTOR MODEL 3550-29| LEAD MODEL 3778| ACCESSORY MODEL 37752| PROGRAMMER MODEL 37743| NEUROSTIMULATOR MODEL 37711| EXPLANTED| IMPLANTED| EXPLANTED