BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2181463 · Received July 5, 2011

    Report

    Report Number
    3004209178-2011-05078
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    January 1, 2009
    Report Date
    June 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS TURNING ON WITH NO COMMUNICATION WITH THE PT PROGRAMMER (PP), AND THEN THE PP COULD NOT TURN THE STIMULATION OFF. THE PT ALSO COULD NOT ADJUST STIMULATION AND HAD HAD PROBLEMS WITH THE STIMULATION SINCE 2009. ONCE THE STIMULATION WAS ON, IT WAS HARD TO TURN OFF WITH THE PP. THE PP SHOWED THE GREEN "STIMULATION ON" LIGHT, BUT THE YELLOW "STIMULATION OFF" LIGHT ALSO FLICKERED. THE DEVICE WAS TURNED OFF USING A PHYSICIAN PROGRAMMER. THE CAUSE OF THE EVENT WAS NOT IDENTIFIED. NO FURTHER ISSUES WERE FOUND. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT WHEN ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU077076V| PROGRAMMER: MODEL 7434A, LOT# NGL020834P| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3587A, LOT# LC4749