BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2190784 · Received July 26, 2011

    Report

    Report Number
    1644487-2011-01688
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    January 24, 2011
    Report Date
    July 8, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES THAT A VNS PT WAS HAVING INCREASE IN SEIZURES, VOICE HOARSENESS, AND ASPIRATION. ON (B)(6) 2011, THE NEUROLOGIST REFERRED THE PT FOR GENERATOR REPLACEMENT SINCE IT WAS NEAR END OF SERVICE. THE GENERATOR WAS RECEIVED BY THE MFR AND CURRENTLY IS UNDERGOING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 010960

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention