BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1061966 · Received June 16, 2008

    Report

    Report Number
    3004209178-2008-03256
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    November 28, 2007
    Report Date
    May 15, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: OTHER = LEAD X 2.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD A LEAD REVISION DUE TO THE DEVELOPMENT OF RIB AND CHEST WALL STIMULATION. THE LEADS WERE SWITCHED TO A TRIPOLE ARRAY. NO OUTCOME WAS REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 48 YR Required Intervention LOT# NKA027036N| LEAD MODEL 377860| LEAD MODEL 377860| EXPLANTED:| PROGRAMMER MODEL 37742| EXTERNAL PT RECHARGER SYSTEM MODEL 37752| EXPLANTED: