BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2081388 · Received April 22, 2011

    Report

    Report Number
    1644487-2011-00876
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO OUR COUNTRY REPRESENTATIVE IN (B)(4) BY A VNS PROGRAMMING NURSE THAT THEY HAD A VNS PATIENT WHO WAS LAST SEEN IN (B)(6) 2010 AND SET TO AT THAT TIME OUTPUT CURRENT OF 1.25 MA. IN (B)(6) 2010, THE PATIENT WAS DOING WELL, SINCE (B)(6) 2011 THEY NOTICED AN ACCOMPANYING INCREASE IN ATTACKS (SEIZURES), MORE VIOLENT ATTACKS, LESS MAGNETIC EFFECT, OFTEN STESOLID NEEDED. THEIR SEIZURES WERE NOT OVER THEIR PREVNS RATE DURING THIS TIME AND LATER ATTRIBUTED TO THEIR LOSS OF THERAPY. ON INTERROGATION IN (B)(6) 2011, A SCREEN WARNING THAT THE OUTPUT STOOD AT 0.00 MA WAS NOTED ON THE REGULAR OUTPUT CURRENT AND THE MAGNET OUTPUT CURRENT. THE PATIENT'S SETTINGS WERE CORRECTED TO INTENDED THERAPY OF 1.25MA OUTPUT CURRENT AND 1.50MA OUTPUT CURRENT ON THE MAGNET. SYSTEM DIAGNOSTICS WERE PERFORMED AND SHOWED: EVERYTHING IS OK AT 1.25 MA, 3387 OHMS, IFI NO. MANUFACTURER IS PENDING REVIEW OF PROGRAMMING HISTORY TO CONFIRM THE EVENT. IT IS LIKELY BASED ON THE REPORT OF EVENTS THAT A GENERATOR RESET DUE TO BURST WATCHDOG TIMEOUT OCCURRED. A SOFTWARE UPGRADE WILL BE SCHEDULED ON THE PATIENT'S GENERATOR TO PREVENT FUTURE RESET EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200604

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention