BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1230643 · Received November 6, 2008

    Report

    Report Number
    3004209178-2008-07286
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED INCREASED PAIN IN THE LEGS AND NO STIMULATION SENSATION. THE PT HAS FALLEN SINCE IMPLANT; THE PT'S "HER LEGS GAVE OUT". THE PT HAS FALLEN ALMOST EVERY DAY AT LEAST ONCE. THE PT HAS NEVER TURNED THE STIMULATOR OFF BECAUSE SHE IS AFRAID SHE WON'T BE ALBE TO WALK. THE PT WAS SCHEDULED TO SEE THE PHYSICIAN FOR REPROGRAMMING. THE PT WAS AT HOME IN GOOD CONDITION AT THE TIME OF THE CALL. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 53 YR LEAD: MODEL 39565| RECHARGER SYSTEM: MODEL 37752| PROGRAMMER: MODEL 37743| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081| EXTENSION: MODEL 37081| EXPLANTED:| IMPLANTED: