BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1761280 · Received July 15, 2010

    Report

    Report Number
    1644487-2010-01638
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH AN IMPLANT CARD THAT A VNS PT WAS REPLACED OF BOTH GENERATOR AND LEAD DUE TO "ELECTRODE NERVE CONTACT SCARRING". FURTHER INFO WAS RECEIVED FROM THE EXPLANTING PHYSICIAN THROUGH A COMPANY REP INDICATING THAT PRIOR TO REPLACEMENT SURGERY, PRE-OP DIAGNOSTICS WERE INDICATIVE OF A HIGH LEAD IMPEDANCE. THE SURGEON EXPECTED A BROKEN LEAD WHEN SURGERY WAS PERFORMED AND WAS ABLE TO NOTICE THE LEAD WAS BROKEN ALONG WITH SCAR TISSUE FORMATION BETWEEN THE ELECTRODE AND THE VAGUS NERVE. HOWEVER, THE SURGEON IS NOT SURE IF HE BROKE THE LEAD AT THE TIME OF SURGERY OR IF THE SCAR TISSUE WAS CAUSING THE HIGH LEAD IMPEDANCE. NO X-RAYS WERE TAKEN AND NO PT MANIPULATION OR TRAUMA WAS REPORTED TO HAVE CONTRIBUTED TO THE HIGH LEAD IMPEDANCE. MOREOVER, ALL EXPLANTED PRODUCTS ARE NOT BEING RETURNED TO THE MFR AS THEY WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 739

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR