BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1000881 · Received February 21, 2008

    Report

    Report Number
    1644487-2008-00367
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    March 20, 2007
    Report Date
    January 23, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE A DEATH.

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THE PT WAS HAVING AN INCREASE IN SEIZURES UNK AT THIS TIME IF OVER THEIR PRE VNS IMPLANTATION RATE. PT HAS SEVERAL SCREAMING SEIZURES A DAY AND FALLS TO THE GROUND. ADDITIONALLY IT WAS REPORTED THE PT HAD "A PROBLEM WITH THE LEAD IMPEDANCE" INDICATING A POSSIBLE LEAD MALFUNCTION. NO SURGICAL INTERVENTION IS PLANNED FOR THE PT AT THIS TIME. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADDITIONAL INFO SURROUNDING THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 008902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other