BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1231245 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07448
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 16, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION FOLLOWING 2 HARD FALLS. THE PATIENT WAS AT HOME AT THE TIME OF THE REPORT; HIS STATUS WAS REPORTED AS 'GOOD.' 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 ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR EXTENSION: MODEL 37081| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743| EXPLANTED:| EXTENSION: MODEL 37081| RECHARGER: MODEL 37752