BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1230559 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07454
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    June 1, 2007
    Report Date
    October 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT HAD BEEN "GETTING ELECTROCUTED" FROM THEIR DEVICE SINCE JUNE, 2007 AND COULD NOT USE IT. THE PT WANTED THE DEVICE REMOVED. ADDITIONAL INFO INDICATED THE PT WAS REFERRED TO SEE THE IMPLANTING PHYSICIAN IN 2007. THE DEVICE WAS EXPLANTED, AND RETURNED TO THE MFR. THE EXPLANT DATE IS UNK. IT IS UNK IF A NEW DEVICE WAS IMPLANTED.

    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 EXPLANTED:| PROGRAMMER: MODEL 37742| EXPLANTED:| LEAD: MODEL 3777| STIM ACCESSORY: MODEL PLUG/IPG| IMPLANTED:| IMPLANTED: