BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1063602 · Received June 20, 2008

    Report

    Report Number
    1644487-2008-01424
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO MANUFACTURER THAT THE VNS PATIENT WAS HAVING THE GENERATOR REPLACED PROPHYLACTICALLY. ADDITIONAL INFORMATION WAS RECEIVED PRIOR TO SURGERY WHICH REVEALED THAT THE SURGEON WAS INFORMED BY THE PATIENT'S CAREGIVER THAT HIGH LEAD IMPEDANCE RESULTED FROM A PREVIOUS DIAGNOSTIC TEST. THE SURGEON OPTED TO PERFORM A FULL REVISION AND A NEW LEAD AND GENERATOR WERE IMPLANTED. THE SURGEON DID NOT TEST THE DEVICE PRE-OPERATIVELY TO CONFIRM THE HIGH LEAD IMPEDANCE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE TREATING PHYSICIAN HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL TO DATE. THE EXPLANTED LEAD AND GENERATOR HAVE BEEN RETURNED TO MANUFACTURER AND ANALYSIS IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-30 38176C

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR