BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PATIENT RECHARGER SYSTEM

    MDR report key: 1032607 · Received April 22, 2008

    Report

    Report Number
    2182207-2008-02129
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Report Date
    March 24, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT DIDN'T CHARGE THE STIMULATOR FOR APPROX 6 MONTHS DUE TO PROBLEMS WITH RECHARGE COUPLING. THE STIMULATOR WAS OVERDISCHARGED. THE RECHARGER WOULD NOT GO INTO THE PHYSICIAN MODE RECHARGE, THE PT TRIED 5 TIMES AND THE MFR REP TRIED ONCE. THE MFR REP SUCCESSFULLY PERFORMED THE PHYSICIAN MODE RECHARGE USING A DIFFERENT RECHARGER. AT THE TIME OF REPORT, THE PT WAS STILL UNABLE TO CHARGE THE BATTERY AND WAS SCHEDULED FOR REVISION. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAIL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT# NJH702362H IMPLANTED| LEAD MODEL 3998 LOT# J0546731V IMPLANTED| EXPLANTED| EXTENSION MODEL 37083 LOT# NKC00908N IMPLANTED| EXTENSION MODEL 37083 LOT# NKC00909N IMPLANTED| EXPLANTED| EXPLANTED| IMPLANTABLE NEUROSTIMULATOR MODEL 37711| EXPLANTED