BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1941252 · Received December 16, 2010

    Report

    Report Number
    1644487-2010-02821
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS: X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PT HAD HIGH LEAD IMPEDANCE READINGS WITH SYSTEMS AND NORMAL MODE DIAGNOSTICS TESTING. THE VNS WAS DISABLED. THE PT DID NOT HAVE ANY TRAUMA OR MANIPULATE THE VNS. NO ADVERSE PT EVENTS HAVE OCCURRED. X-RAYS WERE REVIEWED BY THE MFR THAT DID NOT IDENTIFY ANY OBVIOUS BREAKS, BUT A SHARP ANGLE IN THE LEAD WAS NOTED JUST ADJACENT TO THE GENERATOR. THE LEAD PINS WERE FULLY INSERTED INTO THE GENERATOR HEADER, SUGGESTING A LEAD FRACTURE IS LIKELY AS A PIN INSERTION ISSUE HAS BEEN RULED OUT. SURGERY TO REPLACE THE VNS LEAD AND GENERATOR IS PLANNED, BUT A SURGERY DATE HAS NOT BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 3979

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR