BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2191109 · Received July 29, 2011

    Report

    Report Number
    1644487-2011-01736
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    January 16, 2011
    Report Date
    June 30, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN CLINIC NOTES THAT THE PATIENT HAD PNEUMONIA. THERE WAS NO ALLEGATION THAT THE PNEUMONIA WAS RELATED TO VNS, HOWEVER, IT WAS UNABLE TO BE CONFIRMED WITH THE PHYSICIAN THAT HE DID NOT FEEL IT WAS RELATED. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 LYJ CYBERONICS, INC. 104 200873

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention