BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2041427 · Received March 24, 2011

    Report

    Report Number
    1644487-2011-00630
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 25, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    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 HIGH IMPEDANCE WAS FOUND UPON INTERROGATION OF THE PT'S VNS. THE PT STATED THAT HE HAD NOT BEEN ABLE TO FEEL STIMULATION SINCE A WEEK PRIOR TO THE OFFICE VISIT. THE PT'S VNS HAS BEEN DISABLED. X-RAYS WERE TAKEN AND FORWARDED TO THE MFR. REVIEW OF THE X-RAYS CONFIRMED A 1.5-2.5 CM LEAD BREAK WAS PRESENT IN THE LOWER NECK. IT IS UNK IF ANY TRAUMA OR MANIPULATION CONTRIBUTED TO THE BREAK. REVIEW OF THE PT'S PROGRAMMING HISTORY AVAILABLE TO MFR FOUND THAT THE SYSTEM DIAGNOSTICS DCDC CODES HAD PREVIOUSLY BEEN FLUCTUATING FROM 2 TO 0 POSSIBLY INDICATING AN INTERMITTENT SHORT CIRCUIT THAT MAY HAVE DEVELOPED INTO THE LEAD FRACTURE. SURGERY TO REPLACE THE PT'S VNS LEAD AND GENERATOR IS LIKELY.

    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 46 YR