BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1880381 · Received October 15, 2010

    Report

    Report Number
    1644487-2010-02320
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS: REVIEW OF X-RAYS BY THE MANUFACTURER REVEAL A GROSS LEAD DISCONTINUITY. CONCLUSIONS: DEVICE FAILURE OCCURRED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT HIGH LEAD IMPEDANCE WAS OBSERVED ON DIAGNOSTICS PERFORMED. THE PATIENT WAS REPORTING AN INCREASE IN SEIZURE FREQUENCY OF A DIFFERENT TYPE FOR THE PREVIOUS FIVE MONTHS, BUT WAS STILL BELOW PRE-VNS BASELINE LEVELS. THE PATIENT WAS SAID TO BE MEDICATION COMPLIANT SO IT IS UNCLEAR IF THE RECENT CHANGE IN BEHAVIORS AND SEIZURE ACTIVITY WAS DUE TO THE DEVICE. SHE SAID, THE PATIENT IS A TEENAGER, SO THE POSSIBILITY OF DISEASE PROGRESSION OR PHYSIOLOGICAL CHANGES HAS NOT BEEN COMPLETELY RULED OUT. THE ISSUES WERE LATER INDICATED AS NOT BEING NEW, JUST ISSUES THAT HE HASN'T DISPLAYED IN A REALLY LONG TIME AND SINCE BEFORE VNS. THE PATIENT WAS SAID TO HAVE BEEN REFERRED FOR X-RAYS AT THAT TIME. REVIEW OF THE X-RAYS RECEIVED INDICATED THAT THERE APPEARS TO BE A LEAD FRACTURE THAT IS LIKELY CONTRIBUTING TO THE HIGH LEAD IMPEDANCE OBSERVED. A SEARCH PERFORMED IN THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE RESULTED IN PREVIOUSLY OBSERVED HIGH LEAD IMPEDANCE ON 07/16/2008. THE PATIENT HAS BEEN REFERRED FOR REVISION SURGERY OF THE LEAD AND PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 009206

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention