BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1843804 · Received September 22, 2010

    Report

    Report Number
    1644487-2010-02146
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. RESULTS CODE: REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PATIENT WAS HAVING HER VNS REMOVED DUE TO INFECTION. DEVICE HISTORY RECORDS INDICATE THE VNS WAS STERILE WHEN SHIPPED FROM THE MANUFACTURER. SURGERY TO REMOVE THE VNS HAS OCCURED AND THE EXPLANTED VNS LEAD AND GENERATOR HAVE BEEN RETURNED AND ARE CURRENTLY UNDERGOING ANALYSIS. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 2701

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R