BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1052420 · Received May 21, 2008

    Report

    Report Number
    1644487-2008-01187
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 6, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PATIENT HAD A LEAD FRACTURE DURING A LEAD REVISION SURGERY. A LEAD FRACTURE WAS NOT VISUALIZED BY THE REPORTER. X-RAYS WERE TAKEN BUT WERE NOT RELEASED TO THE MANUFACTURER. HIGH LEAD IMPEDANCE READINGS WERE OBTAINED FIVE DAYS PRIOR TO SURGERY AND THE VNS WAS DISABLED. THE PATIENT WAS ALSO EXPERIENCING AN INCREASE IN SEIZURES. IT IS NOT KNOWN IF THE SEIZURE INCREASE WAS GREATER THAN PRE-VNS BASELINE LEVELS OR IF THERE WAS ANY PATIENT TRAUMA OR DEVICE MANIPULATION. DUE TO INCOMPATIBILITY WITH THE NEW LEAD, THE PATIENT ALSO RECEIVED A NEW GENERATOR. THE EXPLANTED LEAD AND GENERATOR WERE DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ LYJ CYBERONICS, INC. 300-20 2132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other