BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1823569 · Received August 27, 2010

    Report

    Report Number
    1644487-2010-01964
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    June 20, 2006
    Report Date
    July 28, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED HIGH LEAD IMPEDANCE READINGS DURING A ROUTINE OFFICE VISIT. THERE WERE NO REPORTS OF TRAUMA OR MANIPULATION. IT WAS RECOMMENDED THAT THE PATIENT'S DEVICE BE PROGRAMMED OFF AND X-RAYS BE TAKEN. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE CURRENTLY BEING MADE. THE PATIENT'S PROGRAMMING HISTORY AVAILABLE IN THE IN-HOUSE DATABASE WAS REVIEWED AND FOUND TO BE CURRENT FROM (B)(6) 2005 TO (B)(6) 2008. HIGH LEAD IMPEDANCE READINGS WERE FIRST OBTAINED ON (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 010644

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR