BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL

    MDR report key: 1923218 · Received November 9, 2010

    Report

    Report Number
    3007566237-2010-09134
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    A MFR'S REP MEASURED IMPEDANCES ">10000 OHMS." SHE NOTED "THE 0 & 1 ARE IN RANGE, BUT OTHERS REMAIN TO BE HIGH," INCLUDING "11,000 (2) & 17,000 (3)." A CURRENT CHECK WAS PERFORMED AND 2 AND 3 HAD CURRENT THROUGH THE SYSTEM. NO PT SYMPTOMS WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL LGW MEDTRONIC NEUROMODULATION IPG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LEAD: MODEL 3778, LOT# UNK| IMPLANTED:| EXPLANTED: