BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL

    MDR report key: 2172348 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04769
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIAL PT EXPERIENCED NO STIMULATION SENSATION. THE PT RECEIVED A BRIEF SHOCK WHEN THE STIMULATION WAS AT APPROXIMATELY 4 VOLTS, THEN COULD NOT SUBSEQUENTLY FEEL THE STIMULATION. IT WAS LATER REPORTED THAT THERE WAS NO INJURY TO THE PT. THE TEMPORARY LEADS WERE REMOVED WITHOUT ISSUE, AND THE PT WAS SCHEDULED FOR IMPLANT SURGERY ON (B)(6), 2011. A F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL EZW MEDTRONIC NEUROMODULATION 3625 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK