BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1200060 · Received October 15, 2008

    Report

    Report Number
    3004209178-2008-06582
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 15, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS UNABLE TO ADJUST THE STIMULATION WITH OR WITHOUT THE ANTENNA. THE STIMULATOR WAS ON. THE PT DID NOT FEEL STIMULATION. THE PT HAD RECENTLY FALLEN SEVERAL TIMES. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 83 YR EXPLANTED:| RECHARGER SYSTEM: MODEL 37752| EXPLANTED:| EXTENSION: MODEL 37081| PROGRAMMER: MODEL 37742 LOT # NJD058668N| LEAD: MODEL 3777| IMPLANTED: