BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1071725 · Received July 9, 2008

    Report

    Report Number
    3004209178-2008-03869
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    K840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT EXPERIENCED INTERMITTENT STIMULATION. THE PT HAD A FALL RECENTLY. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO 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 41 YR Required Intervention LEAD: MODEL 39565| EXPLANTED:| PROGRAMMER: MODEL 37742| IMPLANTED:| ACCESSORY: MODEL 37752| IMPLANTED:| EXTENSION: MODEL 37081| EXPLANTED:| EXTENSION: MODEL 37081| EXPLANTED:| IMPLANTED: