BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2950496 · Received February 8, 2013

    Report

    Report Number
    1644487-2013-00341
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    October 30, 2012
    Report Date
    January 10, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 AND (B)(6) 2011 WERE RECEIVED WHICH ALL MENTION THAT THE PATIENT HAS HORNER'S SYNDROME. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IT IS UNKNOWN IF A RELATIONSHIP BETWEEN THE HORNER'S SYNDROME AND VNS EXISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54802 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 009597

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other