BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3221104 · Received July 11, 2013

    Report

    Report Number
    1644487-2013-02075
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 CLINIC NOTES WERE RECEIVED FROM A VNS TREATING PHYSICIAN. REVIEW OF THE CLINIC NOTES DATED (B)(6) 2013 INDICATE THAT THE PATIENT HAD A FLURRY OF SEIZURES TWO DAYS PRIOR AND WAS SEEN IN THE ER. UPON THE PHYSICIAN¿S RECOMMENDATION, THE DOSE OF KEPPRA WAS INCREASED TO 1500MG BID AND SHE HAD NO FURTHER SEIZURES. THE PATIENT STATED THAT SHE FEELS THAT THE HEAT AND HUMIDITY MAY HAVE TRIGGERED THE SPELLS. THE PATIENT DENIED ANY PROBLEMS WITH THE VNS. THE PATIENT HAD BEEN HAVING ABOUT 1 OR 2 SEIZURES A MONTH WHICH SHE DESCRIBED AS ¿LIGHT¿. THE PATIENT¿S SETTINGS WERE NOTED TO BE OUTPUT=2.25MA/ FREQUENCY=30HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=1.8MIN. DIAGNOSTICS WERE ALSO PERFORMED WHICH SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/NEOS=NO. THE PHYSICIAN REPROGRAMMED THE PATIENT TO AN OUTPUT CURRENT OF 2.5MA, AN ON TIME OF 21SEC AND AN OFF TIME OF 1.1MIN. THE PATIENT WAS NOTED TO HAVE TOLERATED THESE CHANGES WELL. THE PHYSICIAN INDICATED THAT THE RECENT EXACERBATION OF HER SEIZURES WAS POSSIBLY TRIGGERED BY THE HEAT AND HUMIDITY BUT HE SUSPECTS ALSO THAT THE VNS IS NEAR THE END OF ITS BATTERY LIFE. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 0.31 YEARS REMAINING UNTIL ERI=YES. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN¿S OFFICE BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT SURGERY TOOK PLACE ON (B)(6) 2013. THE PATIENT'S EXPLANTED DEVICE WAS RETURNED AND PRODUCT ANALYSIS WAS PERFORMED. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319869 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 014168

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other