BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2968799 · Received February 19, 2013

    Report

    Report Number
    1644487-2013-00378
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY. DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THIS VNS PATIENT WAS SEEN ON (B)(6) 2013 WITH HIGH IMPEDANCE (6395 OHMS). THE PATIENT'S SETTINGS WERE 2.0 MA OUTPUT CURRENT, 250 USEC PULSEWIDTH, FREQUENCY 25 HZ. A SYSTEM DIAGNOSTIC TEST INDICATED 1.0 MA CURRENT DELIVERED. THE PATIENT WAS PREVIOUSLY SEEN IN CLINIC IN (B)(6) 2012 WITH NORMAL LEAD IMPEDANCE (4012 OHMS).THERE WAS NO WORSENING OF SEIZURE STATUS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PROGRAMMING AND DIAGNOSTIC HISTORY WAS UNAVAILABLE. THE PATIENT'S DEVICE WAS NOT PROGRAMMED OFF AT THE TIME OF HIGH IMPEDANCE AS IT APPEARED TO BE DELIVERING MOST OF THE OUTPUT CURRENT (1.75 MA) WHICH WAS 0.25 MA BELOW WHAT IT WAS SUPPOSED TO BE DELIVERING. THE PATIENT WAS REFERRED BACK TO ANOTHER FACILITY FOR X-RAYS. NO X-RAYS HAVE BEEN RECEIVED. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72063 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS INC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR