BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1062351 · Received June 18, 2008

    Report

    Report Number
    3004209178-2008-03329
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 20, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELT THE NEUROSTIMULATOR (INS) FLIP TWO TIMES. IT WAS REPORTED THAT IT TOOK ALL DAY TO GET ANY EFFICIENCY BARS WHEN THE PT NEEDED TO RECHARGE HER INS. IT WAS ALSO REPORTED THAT THE PT FELT SOME PRESSURE AT THE SPINE AREA WHERE THE LEAD IS LOCATED. IT WAS REPORTED THAT TWICE THE VOLTAGE WAS NEEDED TO PROVIDE COVERAGE FOR THE PT'S SYMPTOMS. THE PT ALSO REPORTED SEVERE PAIN WHICH SHE HAS NOT FELT IN THE PAST 12 YEARS. ADD'L 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 RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention PROGRAMMER: MODEL 37742| LEAD: MODEL 3778| EXPLANTED| PROGRAMMER: MODEL PROGRAMMER| RECHARGER: MODEL 37752