BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2182180 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05186
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 13, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AFTER SLIPPING AND FALLING IN A SWIMMING POOL. IT WAS SUBSEQUENTLY REPORTED THAT THE PT NEEDED A LEAD REVISION AND POSSIBLE LEAD REPLACEMENT. HER LEADS WERE ALL LEFT OF THE MIDLINE AND SHE NO LONGER RECEIVED STIMULATION COVERAGE ON THE RIGHT SIDE. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 46 YR EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA011900N| EXTENSION: MODEL 37081, LOT# NJB006837N| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB006838N| LEAD: MODEL 3776, LOT# V000952| PROGRAMMER: MODEL 37742, LOT# NJD066139N| IMPLANTED:| LEAD: MODEL 3776, LOT# V000952| IMPLANTED: