BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2092178 · Received April 27, 2011

    Report

    Report Number
    1644487-2011-00903
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    August 19, 2009
    Report Date
    March 29, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS HAVING PAINFUL STIMULATION AT THE NECK AND GENERATOR SITE WHENEVER SHE TRIED TO USE HER MAGNET TO DISABLE THE DEVICE. THE PHYSICIAN REVIEWED THE PT'S SETTINGS AND FOUND THAT THE MAGNET OUTPUT CURRENT WAS SET TO 1.0 MA WHEN IT SHOULD HAVE BEEN SET TO 0 MA. REVIEW OF THE PT'S PROGRAMMING HISTORY BY THE PHYSICIAN WHO REPORTED THE EVENT REVEALED THAT A FAULTED DIAGNOSTIC TEST OCCURRED ON (B)(6) 2009 AND ALL THE SETTINGS WERE CORRECTED HOWEVER THE MAGNET OUTPUT CURRENT WAS LEFT AT 1.0 MA WHEN IT SHOULD HAVE BEEN 0 MA. THE PHYSICIAN STATED THAT SHE BELIEVED THE TEST WAS INTERRUPTED BECAUSE IT IS RUN AT HIGHER SETTINGS THAN WHAT THE PT IS PROGRAMMED TO AND THE PT EXPERIENCED PAIN WHEN THE TEST WAS BEING PERFORMED. THE PHYSICIAN WAS REMINDED OF THE IMPORTANCE OF PERFORMING FINAL INTERROGATIONS TO ENSURE ALL OF THE SETTINGS ARE CORRECT INCLUDING MAGNET SETTINGS. GOOD FAITH ATTEMPTS TO OBTAIN CURRENT PROGRAMMING AND DEVICE DIAGNOSTIC INFO HAVE BEEN UNSUCCESSFUL TO DATE THEREFORE THE PROGRAMMING ANOMALY CANNOT BE CONFIRMED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. 250 523498

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR