BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2830804 · Received November 13, 2012

    Report

    Report Number
    1644487-2012-02992
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 17, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THE LEAD PASSED ALL FINAL TESTING SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED.

    Description of Event or Problem · 1

    REVIEW OF THE VNS LEAD DEVICE HISTORY RECORD CONFIRMED THE LEAD MET ALL FINAL TESTING SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    SURGERY TO REPLACE THE VNS IS NO LONGER PLANNED AS THE PATIENT'S FAMILY DOES NOT WANT TO PROCEED WITH SURGERY. THE VNS REMAINS DISABLED. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    REPORTER INDICATED HIGH LEAD IMPEDANCE WITH VNS SYSTEMS DIAGNOSTICS TESTING WAS NOTED ON (B)(4) 2012 AT AN OFFICE VISIT, AND A LEAD BREAK IS SUSPECTED. THE VNS WAS DISABLED. NO PATIENT TRAUMA OCCURRED, AND THE PATIENT WAS SENT FOR X-RAYS. THE PATIENT HAS ALSO HAD INCREASED SEIZURES THAT ARE FELT TO BE DUE TO THE HIGH IMPEDANCE. THE PATIENT HAS ALSO BEEN HAVING EXCESSIVE DROOLING AND ALTERED MENTAL STATUS WITH THE INCREASED SEIZURES. SURGERY TO REPLACE THE VNS LEAD AND GENERATOR IS LIKELY. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT NOW WISHES TO PROCEED WITH VNS REPLACEMENT SURGERY. ONFI MEDICATION HAS BEEN ADDED TO HELP WITH THE INCREASED SEIZURES. A SURGERY DATE HAS NOT BEEN SET YET, BUT IS LIKELY IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS INC 300-20 443

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention