BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 3022077 · Received March 26, 2013

    Report

    Report Number
    1644487-2013-00824
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A HIGH IMPEDANCE WARNING MESSAGE WITH IMPEDANCE VALUE >10,000 OHMS WAS RECEIVED WHEN THE PATIENT'S GENERATOR WAS INTERROGATED. THE PATIENT HAD THEIR GENERATOR TURNED OFF AND THE PATIENT WAS REFERRED FOR X-RAYS. IT WAS UNKNOWN AT THE TIME IF THERE WAS ANY MANIPULATION OR TRAUMA THAT MAY HAVE CONTRIBUTED TO THE HIGH IMPEDANCE. X-RAYS WERE RECEIVED BY THE MANUFACTURER FOR REVIEW. BASED ON THE X-RAY RECEIVED THERE WAS NOTHING SEEN THAT WOULD INDICATE THERE WAS ANY DAMAGE TO THE GENERATOR OR LEAD HOWEVER THE PRESENCE OF A MICRO-FRACTURE IN THE LEAD CANNOT BE RULED OUT. THERE WAS A SMALL SUSPECT AREA OF THE LEAD NEAR THE GENERATOR BUT BASED ON THE IMAGE AND IMAGE QUALITY IT IS UNABLE TO DETERMINE IF IT MAY BE A POTENTIAL LEAD ISSUE OR JUST AN ARTIFACT OF THE IMAGE. AS THE ENTIRE LEAD COULD NOT BE ASSESSED, CONTINUITY IN THAT PORTION OF THE LEAD CANNOT BE CONFIRMED. THE CONNECTOR PIN MAY NOT BE FULLY INSERTED IN THE GENERATOR AS THE PIN CANNOT BE VISUALIZED PASSED THE CONNECTOR BLOCK. SURGERY IS LIKELY BUT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123236 LEAD MODEL 304 LEAD LYJ CYBERONICS INC 304-20 2930

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR