BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 2933066 · Received January 29, 2013

    Report

    Report Number
    1644487-2013-00228
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    REPORTER INDICATED THE PATIENT HAD VNS LEAD AND GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. ATTEMPTS FOR RETURN OF THE EXPLANTED DEVICES HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    MANUFACTURER FOLLOW UP WITH THE HOSPITAL REVEALED THE EXPLANTED VNS LEAD AND GENERATOR CANNOT BE LOCATED AND WERE LIKELY DISCARDED. REVIEW OF THE LEAD DEVICE HISTORY RECORD DOCUMENTS THE LEAD MET ALL FINAL TESTING REQUIREMENTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTER INDICATED HIGH LEAD IMPEDANCE 10,000 OHMS WAS OBTAINED WITH VNS DIAGNOSTICS TESTING AT AN OFFICE VISIT. THE VNS WAS DISABLED. NO TRAUMA OR DEVICE MANIPULATION OCCURRED. VNS DIAGNOSTICS INDICATED NORMAL DEVICE FUNCTION APPROXIMATELY (B)(6) 2012. X-RAYS WERE REVIEWED BY THE MANUFACTURER. THE ELECTRODES ARE VISUALIZED AT APPROXIMATELY C7 AND ARE SLIGHTLY OUT OF ALIGNMENT; THIS MAY BE DUE TO AN ANATOMICAL VARIANT AS ONLY ONE OF THE TWO AVAILABLE VIEWS SHOWS THE MISALIGNMENT. THE FILM ANGLE DOES NOT ALLOW FOR ADEQUATE PIN INSERTION ASSESSMENT. THE LEAD WIRE IS INTACT AT THE LEAD PIN. THERE IS A SMALL AMOUNT OF LEAD BEHIND THE GENERATOR THAT CANNOT BE ASSESSED. SURGERY TO REVISE THE VNS IS PLANNED, BUT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39456 LEAD MODEL 304 LEAD LYJ CYBERONICS INC 304-20 2725

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR