BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2072393 · Received April 8, 2011

    Report

    Report Number
    1644487-2011-00751
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    USER REPORTED THE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROLOGIST THAT DURING SETTING ADJUSTMENT OF A VNS PATIENT, SHE RECEIVED A LOW OUTPUT ERROR MESSAGE STATING DEVICE IS NOT DELIVERING CURRENT AT THE CURRENT SETTINGS. THE ERROR MESSAGE WAS RECEIVED WHEN THE PHYSICIAN INCREASED THE OUTPUT CURRENT FROM 3 MA TO 3.25 MA. PATIENT'S SETTINGS PRIOR TO ERROR MESSAGE WERE ((B)(6) 2011) NORMAL MODE: 3/30/500/30/3 AND MAGNET MODE: 3.25/1000/60. NORMAL DIAGNOSTICS INDICATED THAT RESULTS FOR THIS PATIENT WERE AS FOLLOWS: OUTPUT CURRENT=3 MA, LEAD IMPEDANCE=OK, OUTPUT CURRENT=OK, IMPEDANCE VALUE=2571 OHMS, IFI=NO. HOWEVER, AFTER THE SETTINGS WERE CHANGED TO THE BELOW SETTINGS THE ERROR MESSAGE WAS RECEIVED. ((B)(6) 2011) NORMAL MODE: 3.25/30/750/30/3 AND MAGNET MODE: 3.5/500/60. MANUFACTURER'S REPRESENTATIVE SUCCESSFULLY REPRODUCED THE PROBLEM LATER AND THE NORMAL MODE DIAGNOSTICS WERE ((B)(6) 2011) NORMAL MODE DIAGNOSTICS: OUTPUT STATUS=LOW, LEAD IMPEDANCE=OK, IMPEDANCE VALUE=2530 OHMS AND IFI=NO. THE TREATING NEUROLOGIST REDUCED THE PULSE WIDTH TO 250USECONDS AND THE ERROR MESSAGE DID NOT APPEAR. ((B)(6) 2011) NORMAL MODEL DIAGNOSTICS: OUTPUT STATUS=OK, LEAD IMPEDANCE=OK, IMPEDANCE VALUE=2489 OHMS AND IFI=NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 831033

    Patients

    Seq Age Sex Outcome Treatment
    1 Male