BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2181418 · Received July 6, 2011

    Report

    Report Number
    1644487-2011-01513
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. REVIEW OF X-RAYS BY THE MFR 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

    IT WAS REPORTED THAT THE PT¿S DEVICE SHOWED HIGH IMPEDANCE UPON INTERROGATION. THE PHYSICIAN TURNED THE DEVICE OFF AND IS SENDING THE PT FOR X-RAYS. X-RAYS WERE REVIEWED BY THE MFR. UPON REVIEW, A GROSS LEAD FRACTURE WAS VISUALIZED. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL UNKNOWN LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female