BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 3222520 · Received July 12, 2013

    Report

    Report Number
    1644487-2013-02086
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    April 5, 2012
    Report Date
    June 20, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT WAS SCHEDULED FOR A FULL REVISION SURGERY. THE PATIENT WAS CONCERNED ABOUT HER LEAD BECAUSE SHE CAN FEEL IT. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 AND IT WAS STATED THAT ONLY THE GENERATOR WAS REPLACED. PRE-OPERATIVE DIAGNOSTICS ON THE OLD GENERATOR SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/DCDC=2/ERI=NO. THE PATIENT WAS REPROGRAMMED BACK TO HER PREVIOUS SETTINGS OF OUTPUT=1.5MA/FREQUENCY=20HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=1.1MA/MAGNET OUTPUT=1.75MA/MAGNET ON TIME=60SEC/MAGNET PULSE WIDTH=250USEC. THE EXPLANTED GENERATOR WAS DISCARDED BY THE HOSPITAL AND THEREFORE WILL NOT BE RETURNED FOR PRODUCT ANALYSIS. CLINIC NOTES DATED (B)(6) 2012 WERE PREVIOUSLY RECEIVED INDICATING THAT THE PATIENT HAS A RECURRENT HEADACHE IN THE LEFT NECK/HEAD AND THINKS IT IS DUE TO THE LEAD. THE VNS WAS CHECKED DURING THIS VISIT AND WAS NOTED TO BE ¿IN GOOD ORDER¿. THE CLINIC NOTES MENTION THAT THE VNS LEAD IS TENDER IN THE NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322440 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 9307

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other