BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2200841 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06122
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 12, 2011
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROSTIMULATOR WAS EXPLANTED AND REPLACED BECAUSE THE PT COULD NOT GET THE DEVICE TO FULLY CHARGE, EVEN IF THE RECHARGER WAS ON FOR 8 HOURS. NORMAL BATTERY DEPLETION WAS NOTED. ADD'L INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 56 YR Required Intervention ACCESSORY: MODEL 37752, LOT# NKA152762N| LEAD: MODEL 39565-65, LOT# V661726023| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE167781N