BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1924650 · Received December 7, 2010

    Report

    Report Number
    1644487-2010-02741
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    June 24, 2010
    Report Date
    November 9, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A PATIENT'S VNS GENERATOR WAS EXPLANTED DUE TO PAIN AND WAS NOT REPLACED. MANUFACTURER REVIEW OF AVAILABLE VNS PROGRAMMING HISTORY NOTED THE VNS WAS DISABLED IN (B)(6) 2009. ATTEMPTS FOR FURTHER INFORMATION AND RETURN OF THE EXPLANTED GENERATOR ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 014585

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention