BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1203508 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06659
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT LOST THERAPEUTIC EFFECT FOLLOWING A FALL. THE PT HAS HAD NUMEROUS FALLS AND WAS USING A WALKER. THE PT WAS SEEN BY THE MANUFACTURER'S REP AT THE CLINIC. IMPEDANCE READINGS WERE >40,000 OHMS ON ALL COMBINATIONS WITH ELECTRODES 0,2 AND 5. OTHER COMBINATIONS WERE NORMAL. THERAPY IMPEDANCES WERE IN THE NORMAL RANGE. REPROGRAMMING AROUND THE ELECTRODES WAS DISCUSSED WITH THE REP TO AVOID THE OPEN CIRCUITS AND RECAPTURE STIMULATION. THE PT WAS IN FAIR CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR ACCESSORY: MODEL 37752| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3998| EXTENSION: MODEL 37082| PROGRAMMER: MODEL 37742| EXPLANTED:| EXPLANTED: