BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1082992 · Received July 28, 2008

    Report

    Report Number
    3004209178-2008-04456
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 1, 2007
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A POORLY-DEFINED SHOCKING-TYPE SENSATION EVEN WHEN THE STIMULATOR WAS TURNED OFF. THE PT ALSO EXPERIENCED INADEQUATE PAIN RELIEF AND A CHANGE IN STIMULATION SENSATION. IT WAS DETERMINED THE PT'S LEADS HAD MIGRATE DOWN 3 VERTEBRAL BODIES. THE PT UNDERWENT SURGICAL REVISION, AND THE LEAD WAS MOVED HIGHER. THE LEAD STAYED HIGHER FOLLOWING REVISION, AND THE PT WAS GETTING ADEQUATE STIMULATION. IT WAS ALSO REPORTED THAT A NEW LEAD WAS GUIDED UNDER FLUOROSCOPY TO THE LEVEL CORRESPONDING TO THE TOP OF T8 TO THE RIGHT OF THE OLD LEAD. THE PT REPORTED OPTIMAL STIMULATION COVERING HER PAINFUL AREAS. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| LEAD MODEL 3778 LOT # V02181| PROGRAMMER MODEL 37742 LOT# NJD042494N| LEAD MODEL 3778 LOT # V02181| ACCESSORY MODEL 37752 LOT# NKA028748N