BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 2915675 · Received January 15, 2013

    Report

    Report Number
    1644487-2013-00152
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN IT WAS REPORTED THAT THE VNS PATIENT HAS DECIDED TO HOLD OFF ON REVISION FOR A WHILE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ON (B)(4) 2012 IT WAS REPORTED THAT THE VNS PATIENT HAS HIGH IMPEDANCE AND NO SYMPTOMS. X-RAYS WERE RECEIVED AND REVIEWED. THE GENERATOR IS UNABLE TO BE VISUALIZED IN THE LEFT CHEST AND HENCE IT IS UNABLE TO BE ASSESSED IF THE GENERATOR APPEARS TO BE IN A NORMAL ORIENTATION. DUE TO THE IMAGES RECEIVED, IT IS UNABLE TO BE ASSESSED IF THE LEAD PIN APPEARS TO BE FULLY INSERTED INTO THE CONNECTOR BLOCK. IT IS UNABLE TO BE ASSESSED IF THE FILTER FEEDTHRU WIRES APPEAR INTACT AND IF THE LEAD WIRES APPEAR INTACT AT THE CONNECTOR PIN. THERE DID NOT APPEAR TO BE A GROSS DISCONTINUITY IN THE PORTIONS OF THE LEAD THAT COULD BE VISUALIZED IN THE IMAGES PROVIDED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN WERE UNSUCCESSFUL. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22132 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-30 3004

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR