BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXTERNAL PATIENT RECHARGER SYSTEM

    MDR report key: 972125 · Received December 19, 2007

    Report

    Report Number
    2182207-2007-04515
    Event Type
    Other
    Date Received
    December 19, 2007
    Date of Event
    May 1, 2007
    Report Date
    November 19, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS NOT HAD STIM FOR 6 MONTHS BECAUSE OF PERSONAL ISSUES RELATED TO HIS UNDERLYING DISEASE AND WAS NOT RECHARGING. THE PT HAS PERFORMED 2 PHYSICIAN MODE RECHARGES AT HOME ALREADY WITHOUT EFFECT. THE PT IS NOT GETTING ANY STIMULATION AND THE SYSTEM DOES NOT APPEAR TO BE WORKING AFTER 3 ATTEMPTS USING THE PHYSICIAN MODE RECHARGE. THE PLAN IS FOR THE STIMULATOR TO BE REPLACED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PATIENT RECHARGER SYSTEM LGW MEDTRONIC NEUROMODULATION 37752 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR IMPLANTED:| LEAD MODEL 3777 LOT# N0039833| EXPLANTED: