BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1823577 · Received August 27, 2010

    Report

    Report Number
    1644487-2010-01979
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    May 1, 2010
    Report Date
    July 30, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE 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 THE PT SHOWED HIGH LEAD IMPEDANCE ON SYSTEM MODE DIAGNOSTICS. PT'S DEVICE WAS LAST CHECKED IN (B)(6) 2009 AND EVERYTHING WAS WORKING FINE THAT TIME. PT DID NOT REPORT ABOUT ANY PAIN OR INCREASE IN SEIZURES DUE TO HIGH LEAD IMPEDANCE. PT IS REFERRED TO THE SURGEON FOR A FULL REVISION SURGERY. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR