BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 2172140 · Received June 15, 2011

    Report

    Report Number
    3007566237-2011-04434
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    January 1, 2009
    Report Date
    February 13, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL EXPERIENCED DIFFICULTY PASSING AND PLACING THE LEAD DURING IMPLANT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN LGW MEDTRONIC NEUROMODULATION UNKNOWN/STIM NA

    Patients

    Seq Age Sex Outcome Treatment
    1