BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENS

    MDR report key: 2090847 · Received April 26, 2011

    Report

    Report Number
    3007566237-2011-03094
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Report Date
    April 7, 2011
    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 TRIAL PT EXPERIENCED RANDOM SHOCKING SENSATIONS. THE LEADS COULD HAVE BEEN TOUCHING OR AT LEAST CLOSE TO TOUCHING. THE TRIAL LEADS WERE PULLED AND THE PT WAS NOT GOING TO IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENS LGW MEDTRONIC NEUROMODULATION 37022 NA

    Patients

    Seq Age Sex Outcome Treatment
    1