BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3901913 · Received June 30, 2014

    Report

    Report Number
    1644487-2014-01624
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    April 3, 2013
    Report Date
    June 4, 2014
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE VNS PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2013. THE GENERATOR WAS REPLACED DUE TO BATTERY DEPLETION. THE REASON FOR LEAD REPLACEMENT WAS NOT LISTED. THE EXPLANTING FACILITY WILL NOT RETURN EXPLANTED DEVICES TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, NO ANALYSIS CAN BE PERFORMED. REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY FOUND MULTIPLE SYSTEM DIAGNOSTIC RESULTS FROM THE DATE OF SURGERY SHOWING HIGH IMPEDANCE (IMPEDANCE VALUE >= 10,000 OHMS). THE GENERATOR WAS AT END OF SERVICE BY THE TIME SURGERY OCCURRED AND HIGH IMPEDANCE WAS DETECTED WITH THE REPLACEMENT GENERATOR. TROUBLESHOOTING WAS LIKELY PERFORMED AS EVIDENCED BY THE FOUR DIAGNOSTIC TESTS; HOWEVER IT WAS UNSUCCESSFUL AT RESOLVING THE HIGH IMPEDANCE. AFTER THE LEAD WAS REPLACED, THE HIGH IMPEDANCE RESOLVED. REVIEW OF THE DECODER DATA SHOWED THAT THE LAST 25% CHANGE IN THE IMPEDANCE VALUE WAS ON (B)(6) 2013, WHERE THE IMPEDANCE VALUE CHANGED FROM A NORMAL LIMITS RANGE TO HIGH LEAD IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381274 LEAD MODEL 302 LEAD LYJ CYBERONICS 302-20 200635

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR