BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL UNK

    MDR report key: 1120671 · Received August 14, 2008

    Report

    Report Number
    1644487-2008-01905
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE VNS PT HAD AN MRI SCHEDULED TO "CHECK ON THE STATUS OF THE PATIENT'S HEARING." THE PT REPORTEDLY HAS BEEN HAVING SOME PROBLEMS HEARING IN THE LEFT EAR AND THE DOCTOR WANTS TO RULE OUT THAT THE ELECTRODES THAT MIGHT BE CAUSING HEARING PROBLEMS. ATTEMPTS TO OBTAIN ADD'L INFO ARE UNDERWAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability