BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESUME

    MDR report key: 1052623 · Received May 27, 2008

    Report

    Report Number
    6000153-2008-02803
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.,
    Product Code
    GZB
    PMA / PMN Number
    K884948
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED CENTRAL NERVOUS PAIN IN THE LEFT HYPOTHALAMUS. THE LEAD WAS PLACED UNDER THE ARACHNOID MATER IN THE BRAIN. THE THERAPY EFFECT SUBSIDED AFTER THREE MOS. PROGRAMMING OCCURRED IN EARLY 2008. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESUME GZB MEDTRONIC PUERTO RICO OPERATIONS CO., 3587A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION MODEL 7489| EXPLANTED:| LOT # NAT155192H| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 7425