BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3981130 · Received August 5, 2014

    Report

    Report Number
    1644487-2014-01939
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    May 1, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MANUFACTURER REPORT INADVERTENTLY DID NOT INCLUDE INFORMATION FROM THE PATIENT¿S CLINIC NOTES.

    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

    CLINIC NOTES WERE RECEIVED INDICATING THAT THE PATIENT INITIALLY HAD SOME IMPROVEMENT WITH VNS, BUT HER SEIZURES DID NOT STOP UNTIL ADDITIONAL MEDICATION WAS ADDED. THE PATIENT HAD BEEN SEIZURE FREE FOR APPROXIMATELY THE PAST TWO YEARS, BUT WAS NO LONGER ABLE TO PERCEIVE STIMULATION. THE PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND DIAGNOSTICS REVEALED HIGH IMPEDANCE. THE PATIENT WAS SUBSEQUENTLY PRESCRIBED ADDITIONAL MEDICATION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON 08/11/2014. PRE-OPERATIVE DIAGNOSTICS SHOWED HIGH IMPEDANCE. THE PATIENT¿S REPLACEMENT DEVICE WAS PROGRAMMED ON DURING THE PROCEDURE. THE EXPLANTED PRODUCTS HAVE NOT BEEN RETURNED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR LEAD AND PROPHYLACTIC GENERATOR REPLACEMENT SURGERY DUE TO HIGH IMPEDANCE. CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT BEGAN TO NOTICE THAT HER VOICE NO LONGER CHANGES WITH DEVICE STIMULATION AROUND MAY. THE PATIENT HAS NOT HAD ANY SEIZURES. THE NOTES INDICATE THAT THE MOST RECENT EVALUATION OF THE VNS REVEALED HIGH IMPEDANCE. NO SURGICAL INTERVENTION HAS BEEN PERFORMED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457064 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-30 200462

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR