BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3242676 · Received July 23, 2013

    Report

    Report Number
    1644487-2013-02220
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    ON (B)(4) 2013 INFORMATION WAS RECEIVED FROM THE REPORTER THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES AND AN ALTERED PERCEPTION OF STIMULATION. A REVIEW OF THE MANUFACTURER¿S PROGRAMMING HISTORY DATABASE WAS PERFORMED, SHOWING THAT DATA WAS OBSERVED FROM (B)(6) 2009 (DATE OF IMPLANT) TO (B)(6) 2012. MULTIPLE DIAGNOSTICS TESTS WERE PERFORMED, SHOWING THAT ALL WAS ALRIGHT WITH THE GENERATOR. THE DEVICE WAS LAST AT A 50% DUTY CYCLE. A BATTERY LIFE CALCULATION WAS PERFORMED BASED ON THE AVAILABLE DATA AND PROGRAMMING HISTORY FOR THE GENERATOR, REVEALING IS NOT YET AT NEAR END OF SERVICE AND THE END OF SERVICE FLAG IS AT NO. FOLLOW-UP DETERMINED THAT THE GENERATOR¿S PULSE WIDTH AND SIGNAL FREQUENCY WERE RECENTLY ADJUSTED TO INCREASE THE PATIENT¿S COMFORT, TO THE POINT WHERE SHE IS UNABLE TO FEEL THE STIMULATION. SHE WAS ABLE TO TOLERATE A MORE RECENT INCREASE IN OUTPUT CURRENT. HER MEDICATIONS WERE ALSO INCREASED AND IT WAS STATED THAT THE PATIENT¿S SEIZURE FREQUENCY IS ON A BIG UPTICK AND THAT HER GENERATOR WILL BE MONITORED FOR POTENTIAL REPLACEMENT IN HER NEXT PHYSICIAN VISIT IN SEPTEMBER. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN CONTINUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343159 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2202

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention