BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1150743 · Received September 3, 2008

    Report

    Report Number
    1644487-2008-02085
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    March 27, 2008
    Report Date
    July 31, 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 IS SUSPECTED.

    Description of Event or Problem · 1

    REPORTER INDICATED THE VNS WAS NOT WORKING IN A PATIENT. FURTHER FOLLOW UP REVEALED THE PATIENT HAD HIGH LEAD IMPEDANCE AND THAT VNS REVISION SURGERY WAS PLANNED. THE VNS WAS INITIALLY DISABLED WHEN THE HIGH LEAD IMPEDANCE WAS FIRST NOTED, BUT WAS TURNED BACK ON WHEN THE PATIENT'S SEIZURES BEGAN INCREASING. THE REPORTER WAS AWARE OF THE MFR'S RECOMMENDATION TO DISABLE TO VNS WHEN HIGH LEAD IMPEDANCE IS NOTED. THE PRE-VNS SEIZURE LEVEL IS UNK. NO TRAUMA OR DEVICE MANIPULATION WAS ADMITTED. X-RAYS REVIEWED BY THE REPORTER DID NOT IDENTIFY ANY LEAD DISCONTINUITIES. THE PATIENT LATER UNDERWENT VNS LEAD AND GENERATOR REVISION SURGERY. THE GENERATOR WAS REPLACED PROPHYLACTICALLY. THE EXPLANTED LEAD AND GENERATOR HAVE BEEN RETURNED AND ARE CURRENTLY IN PRODUCT ANALYSIS .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 011114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other