BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1844565 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07244
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE PT EXPERIENCED STIMULATION ON OPPOSITE SIDE OF THE PAINFUL AREA. THE IMPEDANCES WERE CHECKED AND WERE WITHIN NORMAL RANGE. AN X-RAY WAS TAKEN AND IT REVEALED THAT THE LEAD WAS STILL IN THE APPROPRIATE PLACE AS WHEN IMPLANTED. THE PHYSICIAN WANTED TO DO A LEAD REVISION TO MAKE SURE IT WAS NOT A DEVICE RELATED ISSUE. THE LEAD WAS REPLACED AND THE PT RECOVERED WITHOUT SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention LEAD: MODEL 3778, LOT# V016860| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD037489N