BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 4811591 · Received June 2, 2015

    Report

    Report Number
    1644487-2015-04822
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    April 23, 2015
    Report Date
    May 12, 2015
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    INITIALLY, IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY FOR AN UNKNOWN REASON. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT EXPERIENCED AN INCREASE IN NIGHTTIME SEIZURES WHICH THE PHYSICIAN ATTRIBUTED TO THE GENERATOR NEARING END OF SERVICE. IT WAS REPORTED THAT IT WAS UNKNOWN WHETHER OR NOT THE INCREASE IN SEIZURES WAS ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY. THE EXPLANTED GENERATOR WAS DISCARDED BY THE EXPLANTING FACILITY; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355744 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS INC 104 2183

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR