BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1894943 · Received November 5, 2010

    Report

    Report Number
    1644487-2010-02495
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PT WOULD BE HAVING SURGERY TO REVISE THE POCKET AS MIGRATION OF THE VNS GENERATOR HAS OCCURRED. THE SURGERY WAS COMPLETED ON (B)(6) 2010. THE SURGEON'S NORMAL PRACTICE IS TO USE A NON-ABSORBABLE TO SECURE THE VNS GENERATOR. NO TRAUMA HAS BEEN REPORTED. ATTEMPTS FOR PROD INFO HAVE BEEN UNSUCCESSFUL TO DATE. NO DEVICE FAILURE IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention