BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1844762 · Received September 23, 2010

    Report

    Report Number
    1644487-2010-02159
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT HIGH LEAD IMPEDANCE WAS OBSERVED AND THAT THE PT NEEDED TO BE REFERRED FOR REVISION SURGERY. THERE WAS NO KNOWN REPORTED FALLS AND THE CAUSE OF THE HIGH IMPEDANCE WAS UNK. THE PT'S DEVICE WAS NOT DISABLED BECAUSE THE PT WAS NOT REPORTING ANY ADVERSE ISSUES AND HE WANTED TO KEEP THE DEVICE ON. CLINIC NOTES RECEIVED FORM THE TREATING PHYSICIAN INDICATE THAT AT THE APPOINTMENT DATED (B)(6) 2010, THE VNS WAS PERFORMING WITHIN NORMAL LIMITS, BUT SPECIFICS WERE NOT NOTED. THE PT IS NOTED TO BE ON RAPID DUTY CYCLE. A REVIEW OF THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE SHOWED LAST KNOWN DIAGNOSTICS PERFORMED ON (B)(6) 2008 WERE WITHIN NORMAL LIMITS (SYSTEM OK/OK2/NO AND NORMAL MODE 1.50MA/OK/OK2/NO). THE PT IS EXPECTED TO HAVE LEAD AND GENERATOR REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1514

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR