BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2101955 · Received May 18, 2011

    Report

    Report Number
    1644487-2011-01114
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULT: X-RAYS REVIEWED BY MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. CONCLUSION: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S VNS INDICATED HIGH IMPEDANCE AT A ROUTINE OFFICE VISIT. IT WAS INDICATED THAT THE PATIENT HAD A BALL FALL ON HER LEFT SIDE ABOUT TWO WEEKS PRIOR TO THE OFFICE VISIT HOWEVER IT IS UNKNOWN IF THIS EVENT COULD HAVE LED TO THE HIGH IMPEDANCE. IT WAS RECOMMENDED TO THE PHYSICIAN THAT SHE DISABLED THE PATIENT'S VNS STIMULATION. AP AND LATERAL CHEST AND NECK X-RAYS WERE REQUESTED AND RECEIVED BY THE MANUFACTURER. NO ANOMALIES WERE VISUALIZED ON THE X-RAYS HOWEVER THE IMAGES WERE OF POOR QUALITY. THE LEAD PIN DID APPEAR TO BE FULLY INSERTED HOWEVER, INDICATING THAT AN UNPRONOUNCED LEAD DISCONTINUITY IS LIKELY THE CAUSE OF THE HIGH IMPEDANCE. SURGERY TO REPLACE THE PATIENT'S VNS LEAD AND GENERATOR HAS OCCURRED. ATTEMPTS FOR THE RETURN OF THE EXPLANTED PRODUCT ARE IN PROGRESS. NO ADVERSE EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1304

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR