BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 4131542 · Received October 1, 2014

    Report

    Report Number
    1644487-2014-02526
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    March 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM; CORRECTED DATA: THE INITIAL MDR IN ADVERTENTLY DID NOT INCLUDE INFORMATION REGARDING THE RELATIONSHIP OF THE EVENT TO VNS.

    Description of Event or Problem · 1

    THE PATIENT¿S INCREASED SEIZURE FREQUENCY AND SEVERITY WERE NOT RELATED TO VNS. THE PHYSICIAN NOTED THAT THE DEVICE WAS NOT DISABLED DUE TO THE PATIENT¿S SEIZURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS STUDY PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURE FREQUENCY AND SEVERITY SINCE (B)(6) 2014. THE EVENT WAS CLASSIFIED AS SEVERE, CONTINUOUS, AND POSSIBLY RELATED TO VNS STIMULATION. THE PHYSICIAN ELECTED TO DISABLE THE PATIENT¿S DEVICE. IT WAS NOTED THAT THE PATIENT WANTED THE DEVICE DISABLED. FOLLOW-UP REVEALED THAT THE PATIENT¿S SEIZURES TEND TO FLUCTUATE IN FREQUENCY. THE PATIENT HAD DIFFERENT TYPES OF SEIZURES BUT THERE WAS NO INCREASE IN ONE SPECIFIC TYPE. NO FURTHER INFORMATION RELEVANT TO THE EVENT HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611919 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS, INC. 106 3378

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention