BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMIPULSE GENERATORS

    MDR report key: 3882234 · Received June 18, 2014

    Report

    Report Number
    1644487-2014-01533
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 21, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE PATIENT'S INCREASE IN SEIZURES WAS FROM STRESS AND WAS NOT RELATED TO VNS THERAPY. IT WAS REPORTED THAT THE INCREASE WAS BELOW THE PATIENT'S PRE-VNS BASELINE FREQUENCY. THE PATIENT UNDERWENT GENERATOR REPLACEMENT DUE TO BATTERY DEPLETION, NEAR END OF SERVICE ON (B)(6) 2014. THE EXPLANTING FACILITY DISCARDED THE EXPLANTED GENERATOR THEREFORE PRODUCT ANALYSIS WILL NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR GENERATOR REPLACEMENT DUE TO AN INCREASE IN SEIZURES. IT IS UNKNOWN IF THE INCREASE IN SEIZURES IS ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358685 DEMIPULSE GENERATORS PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 3227

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention