BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1935949 · Received December 3, 2010

    Report

    Report Number
    6000032-2010-10192
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT REPORTED THAT STIMULATION WAS TURNING ON BY ITSELF. IT HAPPENED THREE TIMES IN A DAY, ONCE WHILE THE PT WAS PUTTING ON HIS SHOES. THE PT WAS ABLE TO TURN THE DEVICE OFF. THE PROGRAMMER WAS WORKING AS INTENDED. THERE WERE NO NEW SOURCES OF ELECTROMAGNETIC INTERFERENCE IN THE ROOM WHEN IT OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MDT PUERTO RICO OPERATIONS CO, MED REL 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR PROGRAMMER: MODEL 7434A, LOT# NGL011568P| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU007249V| EXPLANTED:| IMPLANTED:| LEAD MODEL 3587A, LOT# LB2027