BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2862439 · Received December 10, 2012

    Report

    Report Number
    1644487-2012-03261
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, A VNS TREATING PHYSICIAN REPORTED TO THEIR CONSULTANT THAT THEY HAD A VNS PATIENT WHO WAS EXPERIENCING NAUSEA AND VOMITING EVER SINCE GETTING DIAGNOSED WITH VOCAL CORD PARALYSIS. THE PATIENT'S NAUSEA AND VOMITING HAVE BEEN NOTED TO BE INTRACTABLE, SO THE VNS DEVICE MAY BE REMOVED DUE TO THESE ISSUES. IT WAS NOTED THAT THIS PATIENT'S ISSUES MAY HAVE BEEN REPORTED PREVIOUSLY; HOWEVER AS THE PATIENT'S NAME AND DATE OF BIRTH ARE UNKNOWN IT CANNOT BE CONFIRMED. THE DATE THE VOCAL CORD PARALYSIS WAS DIAGNOSED AND THE RELATIONSHIP TO VNS ARE UNKNOWN. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention