BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2191217 · Received July 19, 2011

    Report

    Report Number
    1644487-2011-01614
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 20, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAD HIGH IMPEDANCE (DCDC CODE 7) ON SYSTEMS DIAGNOSTICS. THE PT'S DEVICE WAS TURNED OFF AND THERE ARE NO X-RAYS PLANNED. THERE HAS BEEN NO REPORTED TRAUMA OR PT MANIPULATION. THE PT HAS HAD A RECENT INCREASE IN SEIZURES WITH MYOCLONIC JERKING, UNK IF ABOVE OR BELOW BASELINE. THE PT HAD A FULL REVISION WITH A PROPHYLACTIC GENERATOR REPLACEMENT. GOOD FAITH ATTEMPTS FOR MORE INFORMATION AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 1565

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR