BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN

    MDR report key: 1062864 · Received June 18, 2008

    Report

    Report Number
    1644487-2008-01413
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THEY HAD A VNS PT THAT WAS PRESENTING WITH "DIZZINESS DURING 24 HOUR BLOOD PRESSURE MEASUREMENT." IT WAS ASKED IF MFR HAD ANY REPORTS ON THIS AS A SIDE EFFECT FROM THE VNS OR HYPOTONIA AS A SIDE EFFECT. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADD'L DETAILS SURROUNDING THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other