BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2810220 · Received October 31, 2012

    Report

    Report Number
    1644487-2012-02811
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE REPORTER REVEALED THE SEPSIS/PNEUMONIA EVENT THAT REQUIRED HOSPITALIZATION WAS UNRELATED TO THE VNS DEVICE.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT WAS HOSPITALIZED DUE TO SEPSIS/PNEUMONIA IN (B)(6) 2012. THE PATIENT HAS A CHRONIC LESION ON HER BACK THAT KEEPS GETTING RE-INFECTED, BUT IT IS NOT KNOWN IF THIS WAS THE CAUSE OF THE SEPSIS/PNEUMONIA EVENT.ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention