BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD QUAD

    MDR report key: 1991999 · Received February 4, 2011

    Report

    Report Number
    3007566237-2011-00889
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 9, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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

    RECEIVED INFO FROM SEVERAL PHYSICIANS COMPLAINING WHEN THEY USE THE QUAD LEAD AND ARE REMOVING THE NEEDLE AFTER LEAD PLACEMENT, THAT THE NEEDLE GETS "HUNG UP". IF THEY WERE NOT AWARE OF THIS, THE LEAD COULD IN THEORY BE PULLED OUT OF POSITION. ONE PHYSICIAN COMPLAINS THAT WHEN DOING A TRIPOLE HE HAS TO USE BOOTS AND TIES FOR THE EXTENSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1