BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1180486 · Received September 26, 2008

    Report

    Report Number
    1644487-2008-02362
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    June 1, 2008
    Report Date
    August 27, 2008
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PT WAS EXPERIENCING LIGHT CRAMPS IN THE NECK ON THE LEFT SIDE DURING VNS STIMULATION. THE VNS SETTINGS WERE LOWERED, AND THE PT WAS FEELING SOME RELIEF OF THE SYMPTOMS. AN ADDITIONAL REPORT WAS RECEIVED THAT THE MUSCLE CRAMPS CONTINUED TO OCCUR AND WERE GETTING WORSE. THE CRAMPS WERE STILL PRESENT WITHOUT VNS THERAPY STIMULATION. THE PT RECEIVED A BOTOX INJECTION, AND THE MUSCLE CRAMPS HAVE NOW RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention