BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 6012120 · Received October 7, 2016

    Report

    Report Number
    1644487-2016-02283
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 12, 2016
    Report Date
    January 19, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN THE PATIENT'S GENERATOR REPLACEMENT SURGERY, HIGH LEAD IMPEDANCE WAS DETECTED ON A DIAGNOSTIC TEST WITH THE PATIENT'S NEW GENERATOR. THE LEAD WAS NOT REPLACED AT THAT TIME. NO FURTHER SURGICAL INTERVENTION FOR THE HIGH IMPEDANCE HAS OCCURRED TO DATE. ATTEMPTS FOR ADDITIONAL PERTINENT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED SHOWING THAT HIGH IMPEDANCE WAS RECORDED ON THE EXPLANTED GENERATOR IMMEDIATELY PRIOR TO THE PATIENT'S CASE. NO ADDITIONAL PERTINENT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    SURGERY TO REPLACE THE VNS LEAD WAS COMPLETED. THE EXPLANTING FACILITY DOES NOT RETURN EXPLANTED PRODUCTS, SO PRODUCT RETURN IS NOT EXPECTED. NO ADDITIONAL PERTINENT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661794 LEAD MODEL 302 LEAD MUZ CYBERONICS, INC. 302-20 1766

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR