BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1230636 · Received November 6, 2008

    Report

    Report Number
    3004209178-2008-07281
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S BATTERY HAD BEEN EMPTY FOR ABOUT A MONTH. IT WAS ALSO REPORTED THAT THE PT WAS NOT ABLE TO COMMUNICATE WITH THE STIMULATOR USING EITHER THE RECHARGER OR THE PT PROGRAMMER. NO PT SYMPTOMS, TREATMENT, OR OUTCOME WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR LEAD: MODEL 3487A| LEAD: MODEL 3888| PROGRAMMER: MODEL 37742| EXPLANTED:| EXTENSION: MODEL 37082| EXPLANTED:| RECHARGER: MODEL 37752| IMPLANTED:| EXPLANTED: