BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1063533 · Received June 19, 2008

    Report

    Report Number
    1644487-2008-01431
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 23, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    X-RAYS WERE RECEIVED FROM THE REPORTER INDICATING A LEAD BREAK HAD OCCURRED. MANUFACTURER REVIEW OF X-RAYS INDENTIFIED A GROSS LEAD BREAK. FURTHER ATTEMPTS FOR INFORMATION FROM THE REPORTER HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 010324

    Patients

    Seq Age Sex Outcome Treatment
    1