BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULS GEN MODEL 103

    MDR report key: 2973826 · Received February 22, 2013

    Report

    Report Number
    1644487-2013-00484
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 24, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEEN BY THE NEUROSURGEON. IT WAS DETERMINED THAT THE GENERATOR HAD NOT MOVED AND WAS WHERE IT WAS SUPPOSED TO BE. THERE WILL BE NO SURGERY FOR THE REPORTED MIGRATION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT'S GENERATOR HAD MIGRATED TOWARDS THE COLOR BONE. THERE WERE NO REPORTED FALLS BUT THE PATIENT DOES SCRATCH AT IT. THE PATIENT HAS BEEN REFERRED TO A SURGEON FOR SURGERY. IT IS UNCLEAR IF THE MIGRATION IS THE SOLE REASON FOR THE SURGERY. SURGERY IF LIKELY BUT HAS NOT OCCURRED TO DATE. GOOD FAITH ATTEMPT FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78934 PULS GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2817

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention