BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1181775 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06243
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC PUEROT RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT LOST STIMULATION SENSATION WHEN SHE BENT OVER TO PICK UP SOME PAPERS. THE DEVICE WAS IN A POWER ON RESET CONDITION. THE CALL YOUR DOCTOR ICON WAS SEEN ON THE PATIENT PROGRAMMER. THE DIAGNOSTIC CODE ACCOMPANYING ICON WAS UNKNOWN. THE PATIENT WAS WALKED THROUGH A PHYSICIAN MODE RESET OVER THE PHONE. THE NEUROSTIMULATOR BATTERY WAS 75% FULL AND RECHARGING WAS INITIATED. THE PATIENT AS SEEN IN CLINIC. THE DIAGNOSTIC IDENTIFIER AND REASON FOR THE POWER ON RESET WAS NOT CONFIRMED. THE HCP RESET THE TIME OF NEUROSTIMULATOR. IT WAS ALSO REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT IN HER LOWER BACK. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUEROT RICO OPERATIONS CO. 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR LEAD: MODEL 3778| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081| IMPLANTED: