BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1971578 · Received January 25, 2011

    Report

    Report Number
    3004209178-2011-00594
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT DEVELOPED AN INFECTION OVER THE IMPLANTABLE NEUROSTIMULATOR. A CORNER OF THE DEVICE WAS EXPOSED. THERE WAS CONCERN THE WOUND WAS GOING BEHIND THE STIMULATOR. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC005510N| LEAD: MODEL 3998, LOT# V003283| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD016406N| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC005511N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA115951N