BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3240595 · Received July 22, 2013

    Report

    Report Number
    1644487-2013-02196
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, SUSPECT AREA OF LEAD DISCONTINUITY VISUALIZED. DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PHYSICIAN REPORTED A LEAD BREAK IN THIS PATIENT¿S VNS SYSTEM. DIAGNOSTICS IN NOVEMBER (YEAR UNKNOWN) WERE WITHIN NORMAL LIMITS. ON (B)(6) 2013, HIGH IMPEDANCE WAS SEEN (DCDC=7). X-RAYS WERE TAKEN, AND THE PHYSICIAN SAW A CLEAR BREAK. FOLLOW-UP SHOWED THAT THE PATIENTS DEVICE WAS DISABLED ON (B)(6) 2013. THERE WAS NO MANIPULATION BUT THE PATIENT HAD GENERALIZED TONIC-CLONIC SEIZURES. X-RAYS WERE RECEIVED AND REVIEWED. A.P. AND LATERAL CHEST AND AP NECK X-RAYS OF THE PATIENT WERE REVIEWED. THE GENERATOR APPEARS IN THE UPPER LEFT CHEST IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. THE LEAD CONNECTOR PIN WAS FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT BUT THE STRAIN RELIEF AND THE USE OF THE TIE-DOWNS COULD NOT BE FULLY ASSESSED DUE TO A CLEAR LEAD BREAK THAT SEEMS TO HAVE LED TO MISPLACEMENT OF THE LEAD PARTS. PART OF THE LEAD WAS BEHIND THE GENERATOR. ACUTE ANGLES WERE NOT FOUND, BUT THE AFOREMENTIONED LEAD BREAK WAS CLEARLY VISIBLE A FEW INCHES BELOW THE POSITIVE ELECTRODE, CLOSE TO THE LEAD BIFURCATION. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    AN IMPLANT CARD RECEIVED ON (B)(6) 2013 INDICATED THAT THIS VNS PATIENT UNDERWENT LEAD REVISION ON (B)(6) 2013 DUE TO A LEAD DISCONTINUITY. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340785 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 2542

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR