BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1203132 · Received October 17, 2008

    Report

    Report Number
    1644487-2008-02522
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 17, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR INDICATED A VNS PT SOUGHT TREATMENT TO HAVE THEIR VNS EVALUATED, AND COULD NOT PROVIDE ANY FURTHER INFORMATION ABOUT THE PT OR CIRCUMSTANCES OF THE HOSPITAL VISIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1