BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3172859 · Received June 17, 2013

    Report

    Report Number
    1644487-2013-01802
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 17, 2012
    Report Date
    May 23, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT WAS IN A CAR ACCIDENT ON (B)(6) 2012. SINCE THE ACCIDENT, THE PATIENT HAS HAD AN INCREASE IN SEIZURES; BASELINE LEVELS UNKNOWN. DIAGNOSTICS WERE PERFORMED ON (B)(6) 2013 AND WERE WITHIN NORMAL LIMITS; SYSTEM DIAGNOSTICS TEST: OUTPUT=OK/LEAD IMPEDANCE=OK/DCDC=2/ERI=NO AND NORMAL MODE DIAGNOSTICS TEST: OUTPUT=OK/LEAD IMPEDANCE=OK/DCDC=3/ERI=NO. THE PATIENT¿S SETTINGS WERE NOTED TO BE OUTPUT=1.5MA/FREQUENCY=20HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=3MIN. THE CAUSE OF THE INCREASE IN SEIZURES WAS NOT CLEAR, BUT THE PHYSICIAN STATED THAT THE PATIENT¿S SETTINGS NEEDED TO BE ADJUSTED. THE PATIENT¿S SETTINGS WERE INCREASED TO AN OUTPUT OF 1.75MA ON (B)(6) 2013, BUT THE PATIENT HAD PAINFUL STIMULATION IN THE THROAT THAT WAS INTOLERABLE AND THEREFORE, THE PATIENT WAS LOWERED BACK TO 1.5MA ON (B)(6) 2013. NO DIAGNOSTICS WERE PERFORMED AT THE PREVIOUS APPOINTMENT. ADDITIONALLY, THE PATIENT REPORTED THAT THERE WERE A FEW INSTANCES WHERE THE STIMULATION FELT STRONGER THAN NORMAL IN THE NECK ON (B)(6) 2013. THE PHYSICIAN STATED AT THIS TIME HE WAS GOING TO INCREASE THE DUTY CYCLE TO SEE IF THAT HELPS WITH THE RECENT INCREASE IN SEIZURES. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273424 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 2964

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other