BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 3971748 · Received July 31, 2014

    Report

    Report Number
    1644487-2014-01913
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY MANUFACTURER, THE REPORTED EXTRUSION OF THE TIE-DOWNS CANNOT BE ASSESSED OR CONFIRMED.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED FOR THE VNS PATIENT¿S OFFICE VISIT ON (B)(6) 2014. THE NOTES INDICATE THAT THE PATIENT WAS CONCERNED ABOUT POSSIBLE LEAD PROTRUSION. THE PHYSICIAN STATED THAT LEAD IMPEDANCE WAS WITHIN NORMAL LIMITS. IT WAS REPORTED THAT THE PATIENT WENT TO THE ER ON (B)(6) 2014 DUE TO POTENTIAL EXTRUSION OF THE TIE-DOWNS. THE EXTRUSION WAS DESCRIBED AS ¿BLACKHEAD-LIKE THINGS¿ THAT WERE EXTRUDING FROM THE PATIENT¿S NECK. NO ISSUES WITH THE DEVICE WERE OBSERVED. IT WAS NOTED THAT THE PATIENT HAD SOME ITCHY SPOTS AT HER CLAVICLE. X-RAYS DATED (B)(6) 2014 WERE PROVIDED TO THE MANUFACTURER FOR FURTHER REVIEW. THE GENERATOR APPEARS IN THE LEFT CHEST IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES APPEAR TO BE INTACT. THE LEAD CONNECTOR PIN APPEARS FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. ONE SET OF ELECTRODES APPEARS TO HAVE BEEN ABANDONED. PART OF THE LEAD WAS BEHIND THE GENERATOR AND COULD NOT BE ASSESSED. THERE APPEARS TO BE A SHARP ANGLE EXTENDING OUT FROM THE MEDIAL PORTION OF THE GENERATOR. NO CLEAR LEAD BREAKS WERE FOUND IN THE PARTS OF THE LEAD THAT COULD BE ASSESSED. A TIE-DOWN WAS VISUALIZED, SECURING THE STRAIN RELIEF BEND AND LOOP. BASED ON THE IMAGES PROVIDED, THE REPORTED EXTRUSION OF THE TIE-DOWNS CANNOT BE ASSESSED OR CONFIRMED. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SCRATCHED THE SKIN OVER THE LEAD WIRES, BUT THAT THERE WAS NO EXTRUSION. THE PHYSICIAN REPORTED THAT THERE WAS NO BLACK SPOTS PRESENT ON THE PATIENT'S SKIN RELATED TO VNS. THE PHYSICIAN BELIEVES THAT THE PATIENT SCRATCHED THE SKIN DUE TO DEVICE STIMULATION AND THAT THE AREA HAS BEEN COVERED TO DISCOURAGE THE SCRATCHING. THE PHYSICIAN IS CONSIDERING DECREASING THE DEVICE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448080 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1255

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other