BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1913351 · Received November 11, 2010

    Report

    Report Number
    1644487-2010-02545
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A NEW VNS 103 GENERATOR WAS "DEFAULTING" WHEN IT WAS INTERROGATED. THE GENERATOR WAS NOT IMPLANTED IN A PATIENT FOR THIS REASON. IT WAS LATER LEARNED, THE GENERATOR WAS AT END OF SERVICE WHEN INTERROGATED. THE SUSPECT GENERATOR HAS BEEN RETURNED AND IS CURRENTLY IN PRODUCT ANALYSIS. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2740

    Patients

    Seq Age Sex Outcome Treatment
    1