BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2851024 · Received November 29, 2012

    Report

    Report Number
    1644487-2012-03142
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    January 1, 2012
    Report Date
    October 31, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN CLINIC NOTES THAT THE PATIENT WAS EXPERIENCING STROKES. THERE WAS NOT ADDITIONAL INFORMATION PROVIDED AND THERE WAS NO RELATIONSHIP TO VNS NOTED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS INC 101 3821

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other