BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1852351 · Received September 29, 2010

    Report

    Report Number
    1644487-2010-02196
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    January 1, 2006
    Report Date
    September 1, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT HAD THE VNS DEVICE EXPLANTED APPROXIMATELY 4 YEARS AGO, DUE TO INFECTION. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 012565

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR