BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 1052250 · Received May 23, 2008

    Report

    Report Number
    1644487-2008-01219
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 26, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    REPORTER INDICATED A VNS PT PRESENTED WITH HIGH LEAD IMPEDANCE. THE PT HAS NOT BEEN SEEN IN TWO YEARS AS THE PT HAS GOOD SEIZURE CONTROL AND NO HISTORY OF WORSENING SEIZURES. THE SURGEON STATED THE PROBLEM WAS "THE COILS SLIPPED OR STRAIGHTENED," GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1