BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL CORD STIMULATION

    MDR report key: 1831841 · Received September 8, 2010

    Report

    Report Number
    3007566237-2010-06862
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 22, 2010
    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

    IT WAS REPORTED THAT THE PROXIMAL END OF THE LEAD EXTENSION WAS LODGED BETWEEN THE LID AND TRAY OF THE PACKAGING CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL CORD STIMULATION LGW MEDTRONIC NEUROMODULATION 37081

    Patients

    Seq Age Sex Outcome Treatment
    1