BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1252013 · Received December 4, 2008

    Report

    Report Number
    3004209178-2008-08007
    Event Type
    Injury
    Date Received
    December 4, 2008
    Report Date
    November 8, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATION DEVICE WAS REMOVED DUE TO IT "NOT WORKING". IT REPORTEDLY COULD NOT BE ADJUSTED PROPERLY AND WAS "SHOOTING ELECTRODES INTO MY STOMACH CAUSING MORE PAIN." ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT RECEIVED 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 Required Intervention LEAD: MODEL 3777 LOT# V040797036| EXTENSION: MODEL 37081 LOT# NJB012440V| EXTENSION: MODEL 37082 LOT# NKB007967N| EXPLANTED| EXPLANTED| EXPLANTED| LEAD: MODEL 3999 LOT# V035788| EXPLANTED| PROGRAMMER: MODEL 37742 LOT# NJD047633N