BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2061799 · Received March 30, 2011

    Report

    Report Number
    1644487-2011-00673
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED LOW IMPEDANCE READINGS WERE OBTAINED FOR A VNS PATIENT. THE PATIENT IS NOT EXPERIENCING ANY ADVERSE EVENTS. THE PATIENT HAD VNS GENERATOR REPLACEMENT SURGERY ONLY ON (B)(6) 2011. 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 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 009441

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR