BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3192307 · Received June 27, 2013

    Report

    Report Number
    1644487-2013-01940
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 1, 2012
    Report Date
    June 5, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 CLINIC NOTES WERE RECEIVED FROM A VNS TREATING PHYSICIAN. REVIEW OF THE CLINIC NOTES DATED (B)(6) 2013 INDICATED THAT THE VNS PATIENT HAS EXPERIENCED CLUSTERS OF MYOCLONIC SEIZURES AND HEAD DROPS SINCE (B)(6) 2012. IT WAS STATED THAT THE MYOCLONIC SEIZURES WERE OCCURRING 2-4 TIMES A DAY BUT NOW HE HAS THEM ONCE A DAY. IT WAS ALSO STATED THAT PATIENT HAS BEEN EXPERIENCING MYOCLONUS SEIZURES TWICE PER WEEK WHICH THE MOTHER THINKS IS NEW, BUT PREVIOUS CLINIC NOTES INDICATE LONGSTANDING MYOCLONUS. THE PATIENT¿S VNS SETTINGS WERE NOTED TO BE OUTPUT=1MA/FREQUENCY=20HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=5MIN/MAGNET OUTPUT=1.5MA/MAGNET PULSE WIDTH=250USEC/MAGNET ON TIME=60SEC. A SYSTEM DIAGNOSTICS TEST WAS ALSO PERFORMED WHICH SHOWED RESULTS WITHIN NORMAL LIMITS AND EOS=NO. THE CLINIC NOTES ALSO MENTION THAT THE PATIENT IS EXPERIENCING AN INCREASE IN THE FREQUENCY OF HIS TONIC SEIZURES, ESPECIALLY AT NIGHT. THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PATIENT¿S PHYSICIAN BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 5.74 YEARS REMAINING UNTIL ERI=YES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A GENERATOR REPLACEMENT. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED DEVICE WAS RETURNED ON (B)(4) 2013. IN (B)(6) 2013 NOTES, A SYSTEM DIAGNOSTICS TEST WAS ALSO PERFORMED WHICH SHOWED RESULTS WITHIN NORMAL LIMITS AND EOS=NO. THEREFORE, THE EVENT CODING WAS NOT UPDATED TO INDICATED NEOS. ALTHOUGH THE REPORTED ALLEGATION OF ¿CHANGE IN SEIZURE PATTERN¿ AND ¿INCREASED SEIZURES¿ LISTED IN (B)(4) CANNOT BE EVALUATED IN THE PA LABORATORY SETTING, PROPER FUNCTIONALITY OF THE PULSE GENERATOR IN ITS ABILITY TO PROVIDE APPROPRIATE PROGRAMMED OUTPUT CURRENTS CAN BE VERIFIED. IN THE PA LAB, 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 AS DEFINED IN FINAL ELECTRICAL TEST (B)(4). DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293761 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 012303

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other