BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1213275 · Received October 27, 2008

    Report

    Report Number
    3004209178-2008-06923
    Event Type
    Injury
    Date Received
    October 27, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT UNDERWENT A SURGICAL REVISION. NO ADDITIONAL INFO WAS PROVIDED. NO PT SYMPTOMS OR DATES WERE REPORTED. TWO ADDITIONAL SURGICAL REVISION WERE REPORTED. SEE MFR REPORT # 3004209178200806921 AND 3004209178200806924.

    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:| EXTENSION MODEL 37081| LEAD MODEL 3777| EXPLANTED: