BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1031399 · Received April 18, 2008

    Report

    Report Number
    1644487-2008-00957
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED A GROSS LEAD DISCONTINUITY. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT SYSTEM DIAGNOSTICS ON A VNS PT RESULTED IN HIGH LEAD IMPEDANCE. DIAGNOSTICS HAD NOT BEEN PERFORMED BEFORE THE HIGH IMPEDANCE WAS OBTAINED. NO TRAUMA OR PT MANIPULATION WAS REPORTED. THE TREATING PHYSICIAN REVEALED THAT THE PT HAS HAD ESSENTIALLY NO CHANGE IN SEIZURES. X-RAYS WERE PERFORMED AND SENT TO THE MANUFACTURER FOR REVIEW. NO OBVIOUS CAUSE FOR THE HIGH IMPEDANCE WAS FOUND. REVISION SURGERY IS LIKELY. A GROSS FRACTURE OF ONE LEAD COIL WAS IDENTIFIED NEAR A TIE-DOWN. REVISION SURGERY IS LIKELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1