BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2990135 · Received March 5, 2013

    Report

    Report Number
    1644487-2013-00591
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    March 27, 2007
    Report Date
    February 18, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. ANALYSIS OF PROGRAMMING HISTORY. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION. 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 THAT THIS VNS PATIENT WAS SCHEDULED FOR EXPLANT WITHOUT REPLACEMENT FOR AN UNKNOWN REASON. THE PATIENT'S VNS SYSTEM WAS EXPLANTED ON (B)(6) 2012. ATTEMPTS FOR PRODUCT RETURN WERE UNSUCCESSFUL. FOLLOW-UP WITH THE SURGEON SHOWED THAT MOST OF THE LEAD WAS EXPLANTED AND JUST THE ELECTRODES REMAIN ON THE NERVE. THE PATIENT REPORTED FEELING NO STIMULATION SINCE 2007. REVIEW OF PROGRAMMING HISTORY SHOWED THAT HIGH IMPEDANCE WAS SEEN ON (B)(6) 2007. THIS WAS ALSO PRESENT AT A (B)(6) 2007 INTERROGATION. THE DEVICE WAS NOT PROGRAMMED OFF AFTER HIGH IMPEDANCE WAS SEEN. THE DEVICE WAS NOT DISABLED WHEN THE HIGH IMPEDANCE WAS NOTED. A BLC WAS PERFORMED AND RESULTED IN 0 YEARS REMAINING. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94357 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-30 010850

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR