BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1081461 · Received July 25, 2008

    Report

    Report Number
    1644487-2008-01721
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED VNS PT FAINTED ON TWO SEPARATE OCCASIONS WHICH THE PRIMARY CARE PHYSICIAN ATTRIBUTED TO HEAT. FOLLOW UP WITH THE PT'S TREATING NEUROLOGIST REVEALED THE PT EXPERIENCED 2 DROP ATTACKS, WHICH INDICATES A CHANGE IN HIS SEIZURE PATTERN. THE NEUROLOGIST SCHEDULED AN EEG TO CONFIRM THE CHANGE IN SEIZURE PATTERN. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 014788

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention