BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4251812 · Received November 14, 2014

    Report

    Report Number
    1644487-2014-03032
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 REPORTED THAT THE VNS PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND SYSTEM DIAGNOSTIC RESULTS REVEALED HIGH IMPEDANCE. THE PATIENT¿S DEVICE WAS SUBSEQUENTLY DISABLED. IT WAS NOTED THAT THE PATIENT HAS HAD PAIN AT HER LEFT-SIDED UNDERARM FOR APPROXIMATELY TWO YEARS. IT IS UNKNOWN IF THE PAIN WAS RELATED TO VNS AS THE PATIENT HAD SEVERAL SURGERIES FOR OTHER MEDICAL CONDITIONS. AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY (B)(6) 2014. THE EXPLANTING FACILITY WILL NOT RETURN EXPLANTED DEVICES TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, NO ANALYSIS CAN BE PERFORMED. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WILL BE MADE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S PAIN WAS NOT RELATED TO VNS AND NOT OCCURRING WITH STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736198 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200203

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR