BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 858507 · Received June 1, 2007

    Report

    Report Number
    1644487-2007-00755
    Event Type
    Malfunction
    Date Received
    June 1, 2007
    Date of Event
    January 1, 2006
    Report Date
    May 2, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED A GROSS LEAD DISCONTINUITY. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED DEVICE DIAGNOSTIC TESTING YIELDED HIGH LEAD IMPEDANCE. REVIEW OF X-RAYS BY MANUFACTURER INDICATED A LEAD BREAK AROUND THE SECOND RIB. PATIENT UNDERWENT REVISION SURGERY, WHERE THE ENTIRE VNS THERAPY SYSTEM WAS REPLACED. THE VNS THERAPY LEAD AND GENERATOR WERE RETURNED TO MANUFACTURER. PRODUCT ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 1670

    Patients

    Seq Age Sex Outcome Treatment
    1 YR