BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1193449 · Received October 7, 2008

    Report

    Report Number
    3004209178-2008-06400
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST THEIR STIMULATION. THE PATIENT PROGRAMMER DISPLAYED A "CALL YOUR DOCTOR" MESSAGE. THE DEVICE HAD ENTERED A POWER ON RESET CONDITION. FOLLOW UP REVEALED THE PATIENT HAD BEEN ATTEMPTING TO SET UP TO CHARGE THE DEVICE WHEN THE POWER ON RESET OCCURRED. THE DEVICE HAD BEEN REPROGRAMMED THE DAY BEFORE THE EVENT. AT THE TIME OF THE REPROGRAMMING, THE DEVICE WAS AT A 50% CHARGE. FOLLOWING THE POWER ON RESET, THE DEVICE WAS REPROGRAMMED AND THE PATIENT WAS DOING "GREAT".

    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 56 YR Required Intervention LEAD: MODEL 3778| PROGRAMMER: MODEL 37742| EXPLANTED:| LEAD: MODEL 3778| ACCESSORY: MODEL 37752| EXPLANTED: