BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1790305 · Received August 6, 2010

    Report

    Report Number
    1644487-2010-01815
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 8, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PT WAS REFERRED FOR GENERATOR REPLACEMENT SURGERY, DUE TO END OF SERVICE. WHEN THE SURGEON CONNECTED THE NEW DUAL PIN GENERATOR TO THE EXISTING LEAD, HIGH LEAD IMPEDANCE RESULTED. THE SURGEON ATTEMPTED PIN RE-INSERTIONS MULTIPLE TIMES, WITH HIGH LEAD IMPEDANCE RESULTING AFTER EACH ATTEMPT. THE SURGEON THEN CONCLUDED THAT THE LEAD LIKELY HAD A DISCONTINUITY, AND THEREFORE, THE LEAD WAS EXPLANTED AND A NEW LEAD AND GENERATOR WERE IMPLANTED. THE EXPLANTED END OF SERVICE GENERATOR AND THE UNUSED NEW DUAL PIN HAVE BEEN RETURNED TO MFR WHERE ANALYSIS IS UNDERWAY. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE SITE IS UNDERWAY. IN ADDITION, GOOD FAITH ATTEMPTS TO OBTAIN THE DISPOSITION OF THE EXPLANTED LEAD ARE ALSO UNDERWAY. REVIEW OF THE AVAILABLE DIAGNOSTIC HISTORY REVEALED THAT ON 01/05/2009, A SYSTEM DIAGNOSTIC TEST REVEALED NORMAL DEVICE FUNCTION AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 5757

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR