BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2152441 · Received June 22, 2011

    Report

    Report Number
    1644487-2011-01407
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH LEAD IMPEDANCE WAS FOUND DURING SURGERY TO REPLACE THE PT'S GENERATOR DUE TO END OF SERVICE. THE HIGH IMPEDANCE WAS FOUND WHEN THE NEW GENERATOR WAS ATTACHED TO THE EXISTING LEAD. DIAGNOSTICS WERE NOT PERFORMED WITH THE OLD GENERATOR. THE LEAD PIN WAS REMOVED AND RE-INSERTED SEVERAL TIMES; HOWEVER, THE HIGH IMPEDANCE DID NOT RESOLVE. A GENERATOR DIAGNOSTICS TEST SHOWED NO ANOMALIES WITH THE NEW GENERATOR. NO ADVERSE EVENTS HAVE BEEN REPORTED. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    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 28 YR