BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2820371 · Received November 6, 2012

    Report

    Report Number
    1644487-2012-02897
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 15, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY. 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) 2012 AN IMPLANT CARD WAS RECEIVED WHICH INDICATED THAT THE PATIENT HAD A FULL REVISION SURGERY ON (B)(6) 2012 DUE TO A LEAD DISCONTINUITY. THE IMPEDANCE WITH THE NEW VNS SYSTEM WAS REPORTED TO BE WITHIN NORMAL LIMITS. NO X-RAYS WERE PERFORMED AND NO TRAUMA WAS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE LEAD DISCONTINUITY; THE CAUSE OF THE LEAD DISCONTINUITY WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE EXPLANTED LEAD AND GENERATOR WILL NOT BE RETURNED FOR PRODUCT ANALYSIS. THE GENERATOR WAS REPLACED FOR PROPHYLACTIC REASONS. SOME OF THE PATIENT'S PROGRAMMING HISTORY WAS PROVIDED BUT IT DID NOT INDICATE HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS INC 300-20 725

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR