BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL UNK

    MDR report key: 3232904 · Received July 18, 2013

    Report

    Report Number
    1644487-2013-02166
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE CASE MANAGEMENT DISCUSSION WITH A MOTHER WHO IS CONSIDERING VNS IMPLANT FOR HER CHILD, THE MOTHER RELATED A CONCERN SHE HEARD ABOUT VNS. A FRIEND TOLD HER THAT HER NIECE REPORTEDLY HAD STUNTED GROWTH OF THE CAROTID ARTERY AND HEART ISSUES FOLLOWING IMPLANT OF VNS. NO PATIENT INFORMATION OR PHYSICIAN INFORMATION WAS PROVIDED. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE REPORTER HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE INITIAL REPORTER HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333593 LEAD MODEL UNK LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1