BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1915512 · Received November 5, 2010

    Report

    Report Number
    6000032-2010-08961
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    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 THE PT'S DEVICE DISPLAYED IMPEDANCE LEVELS GREATER THAN 4,000 OHMS ON SOME OF THE BIPOLAR PAIRS. IT WAS POSSIBLE TO USE ELECTRODES 0 AND 3, BUT THEN THE STIMULATION HAD TO BE CONTINUALLY TURNED UP IN ORDER FOR THE PT TO FEEL ANY STIMULATION. THERE WAS ALSO AN END OF SERVICE (EOS)/END OF LIFE (EOL) MESSAGE DISPLAYED ON THE PHYSICIAN PROGRAMMER. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADD'L INFO WAS REQUESTED, BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF 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, MED REL 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3586, LOT# LW0001130N| PROGRAMMER: MODEL 7434A, LOT# NGL003145P