BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 3895364 · Received June 25, 2014

    Report

    Report Number
    1644487-2014-01595
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 28, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TO BE CARE FLIGHTED TO THE HOSPITAL AFTER EXPERIENCING TODD'S PARALYSIS WHICH IS CHARACTERIZED BY MANY SEIZURES OCCURRING BACK TO BACK CAUSING SOME KIND OF PARALYSIS OR SENSATION OF PARALYSIS. IT WAS REPORTED THAT THE PATIENT CURRENTLY ADMITTED IN THE HOSPITAL AS AN IN-PATIENT. THE RELATIONSHIP OF THE EVENT TO VNS IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT REPORTED WAS NOT RELATED TO VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370434 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 202211

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R