BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1061961 · Received June 16, 2008

    Report

    Report Number
    3004209178-2008-03261
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 19, 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

    Additional Manufacturer Narrative · 1

    UNABLE TO CONTROL DEVICE.

    Description of Event or Problem · 1

    SINCE THE PT BEGAN RADIATION TREATMENTS FOUR WEEKS AGO, THE DEVICE STOPPED WORKING PROPERLY. THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT IN HIS AREA OF PARESTHESIA AND BEGAN HAVING PAIN NEAR THE TAILBONE. THE PT WAS UNABLE TO CONTROL THE DEVICE. THE PT WAS AT HOME; HIS STATUS WAS "UNDETERMINED". ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention EXPLANTED:| EXPLANTED:| EXTENSION MODEL 7496| LEAD MODEL 3586