BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 2830219 · Received November 13, 2012

    Report

    Report Number
    1644487-2012-02983
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE AT RECENT APPOINTMENT. NO FURTHER INFORMATION IS KNOWN OR WAS PROVIDED. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304 LEAD LYJ CYBERONICS INC 304-20 201736

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR