BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1061626 · Received June 17, 2008

    Report

    Report Number
    1644487-2008-01399
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    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 OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT A LEAD BREAK WAS DISCOVERED AT THE TIME OF A GENERATOR REPLACEMENT OR END OF BATTERY LIFE. THE PATIENT HAD NO REPORT OF A FALL OR INJURY PRECEDING THE LEAD BREAK. THEY DO RIDE IN A SPECIAL CARE SCHOOL BUS WITH AN OVER THE SHOULDER HARNESS BELT. IT IS UNKNOWN IF THIS MAY HAVE CONTRIBUTED TO THE LEAD BREAK. ONCE THE GENERATOR WAS REPLACED WITH A NEW GENERATOR AND A LEAD TEST PERFORMED HIGH LEAD IMPEDANCE WAS ATTAINED. THE EXPLANTED PRODUCT IS AT MFR PENDING COMPLETION OF PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 009063

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR