BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2241413 · Received August 18, 2011

    Report

    Report Number
    1644487-2011-01900
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SURGEON THAT A VNS PATIENT HAD HIGH LEAD IMPEDANCE. THE PATIENT UNDERWENT FULL REVISION ON (B)(6) 2011, WHERE THE LEAD AND GENERATOR WERE REPLACED. ATTEMPTS WILL BE MADE TO OBTAIN MORE INFORMATION REGARDING PATIENT'S HIGH IMPEDANCE AND TO RETRIEVE THE PRODUCT BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 011718

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR