BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 3210839 · Received July 8, 2013

    Report

    Report Number
    1644487-2013-02044
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 14, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT HAD HIGH IMPEDANCE DURING A SYSTEM DIAGNOSTICS TEST WITH AN IMPEDANCE VALUE GREATER THAN 10,000OHMS. IT WAS LATER REPORTED FROM THE PHYSICIAN THAT THE HIGH IMPEDANCE WAS FIRST OBSERVED IN (B)(6) 2013. THE PATIENT WAS REFERRED FOR X-RAYS AND THE PHYSICIAN STATED THAT THERE WAS NO CLEAR LEAD BREAK VISIBLE. NO TRAUMA WAS REPORTED BY THE PATIENT. THE PATIENT HAS A HISTORY OF NOCTURNAL SEIZURES BUT THERE WERE NO FALLS MENTIONED BY THE PARENTS. A COPY OF THE PATIENT¿S X-RAYS WERE RECEIVED FOR REVIEW. THE LEAD CONNECTOR PIN SEEMS TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. NO OBVIOUS LEAD BREAK WAS IDENTIFIED. BASED ON THE X-RAYS IMAGES, NO OBVIOUS CAUSE OF THE REPORTED HIGH IMPEDANCE COULD BE IDENTIFIED. THE PHYSICIAN REPORTED THAT HE PATIENT¿S VNS WAS DISABLED ON (B)(6) 2013 DUE TO THE HIGH IMPEDANCE AND THAT THE PATIENT IS AWAITING SURGERY/REPLACEMENT DEPENDING ON THE PATIENT¿S CLINICAL CONDITION.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310081 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR