BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3941357 · Received July 17, 2014

    Report

    Report Number
    1644487-2014-01813
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    January 1, 2013
    Report Date
    June 23, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED INDICATING THAT THE VNS PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES IN (B)(6) 2013. THE PATIENT¿S DEVICE SETTINGS WERE INCREASED DURING AN OFFICE VISIT ON (B)(6) 2013 AND THE PATIENT SUBSEQUENTLY DEVELOPED THROAT PAIN AND VOICE HOARSENESS. THE PATIENT¿S DEVICE SETTINGS WERE ADJUSTED ON (B)(6) 2013. THE PATIENT DID NOT HAVE ANY SEIZURES BUT CONTINUED TO HAVE PAINFUL STIMULATION. ON (B)(6) 2013, THE PATIENT¿S DEVICE SETTINGS WERE INCREASED AND THE PATIENT REPORTED NO PAIN BUT PERSISTENT VOICE HOARSENESS. FOLLOW-UP REVEALED THAT DIAGNOSTIC RESULTS AT THE TIME SHOWED NORMAL DEVICE FUNCTION. THE PATIENT¿S SEIZURES WERE ABOVE PRE-VNS BASELINE LEVELS, BUT NOT ALL OF THE PATIENT¿S SEIZURES TYPES INCREASED. NO CHANGES OCCURRED TO THE PATIENT¿S MEDICATIONS OR DEVICE SETTINGS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418247 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 200816

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention