BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD MODEL 300

    MDR report key: 2081399 · Received April 22, 2011

    Report

    Report Number
    1644487-2011-00877
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    November 20, 2008
    Report Date
    March 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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

    ON (B)(6) 2011, A VNS TREATING PHYSICIAN REPORTED TO THE MANUFACTURER'S COUNTRY MANAGER IN (B)(6) THAT ON (B)(6) 2009, THE PATIENT HAD A TOTAL REVISION SURGERY DUE TO HIGH LEAD IMPEDANCE AND BECAUSE THE PATIENT COULD NOT FEEL HER STIMULATION. THE DIAGNOSTIC TEST RAN BEFORE THE SURGERY SHOWED A DCDC CODE OF 7 AND HIGH IMPEDANCE. NO ADDITIONAL INFORMATION IS AVAILABLE FROM 2009 AND THE PATIENT'S EXPLANTED PRODUCT WILL NOT BE RETURNED FOR PRODUCT ANALYSIS. THE PATIENT'S PROGRAMMING HISTORY WAS REVIEWED IN THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE AND HIGH IMPEDANCE WAS FIRST NOTED ON (B)(6) 2008 DURING A SYSTEMS DIAGNOSTIC TEST AND A NORMAL MODE DIAGNOSTICS TEST. THE PATIENT CONTINUED TO PRESENT WITH HIGH IMPEDANCE DURING EVERY DIAGNOSTIC TEST SINCE THEN ACCORDING TO THE PROGRAMMING HISTORY. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 5131

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female