BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3180821 · Received June 20, 2013

    Report

    Report Number
    1644487-2013-01865
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 27, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION THAT THE PATIENT HAD NO KNOWN TRAUMA AND DID NOT MANIPULATE THE VNS WAS INADVERTENTLY OMITTED FROM THE INITIAL MDR REPORT.

    Description of Event or Problem · 1

    REPORTER INDICATED HIGH LEAD IMPEDANCE WITH VNS SYSTEMS DIAGNOSTICS TESTING WAS NOTED FOR A PATIENT AT AN OFFICE VISIT ON (B)(6) 2013. NORMAL MODE DIAGNOSTICS RESULTS WERE WITHIN NORMAL LIMITS. NO PATIENT ADVERSE EVENTS HAVE BEEN REPORTED. THE REPORTER ELECTED NOT TO DISABLE THE VNS, BUT THIS WAS RECOMMENDED BY THE MANUFACTURER. X-RAYS WERE RECEIVED AND REVIEWED BY THE MANUFACTURER. THE UPPER PART OF THE GENERATOR IS VISIBLE AND IT APPEARS TO BE IN A NORMAL PLACEMENT IN THE LEFT UPPER CHEST. THE FILTER FEED-THROUGH WIRES APPEAR TO BE INTACT, AND THE LEAD CONNECTOR PIN APPEARS TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE LOWER PART OF THE GENERATOR IS NOT VISIBLE IN THE NECK AP VIEW THAT WAS RECEIVED. THE LEAD IS VISIBLE, APART FROM A SECTION OF THE LEAD THAT IS BEHIND THE GENERATOR AND AN UNDETERMINED LENGTH THAT FALLS OUTSIDE OF THE VISIBLE PARTS OF THE VNS SYSTEM IN X-RAYS. AS THE LEAD PIN IS FULLY INSERTED, A LEAD PIN INSERTION ISSUE HAS BEEN RULED OUT AND A LEAD FRACTURE IS THE MORE LIKELY CAUSE OF THE HIGH LEAD IMPEDANCE. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT HAD NO KNOWN TRAUMA AND DID NOT MANIPULATE THE VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281517 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 1538

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR