BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2871561 · Received December 13, 2012

    Report

    Report Number
    1644487-2012-03324
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    August 3, 2009
    Report Date
    November 21, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING REVIEW OF THE VNS PATIENT'S PROGRAMMING HISTORY ON (B)(6) 2012 IT WAS DISCOVERED THAT ON (B)(6) 2009 A GENERATOR DIAGNOSTICS TEST WAS PERFORMED WHICH CHANGED THE PATIENT'S SETTINGS FROM OUTPUT=0.75MA/FREQUENCY=25HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=3MIN/MAGNET OUTPUT=1MA/MAGNET PULSE WIDTH=250USEC/MAGNET ON TIME=60SEC TO OUTPUT=0MA/FREQUENCY=30HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=5MIN/MAGNET OUTPUT=0MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=60SEC. THE PATIENT WAS REPROGRAMMED TO OUTPUT=0MA/FREQUENCY=30HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=5MIN/MAGNET OUTPUT=1MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=60SEC PRIOR TO LEAVING THE VISIT, BUT THIS DID NOT CORRECT THE ON TIME, FREQUENCY, PULSE WIDTH, OFF TIME, AND MAGNET PULSE WIDTH. IT WASN'T UNTIL THE PATIENT'S VISIT ON (B)(6) 2010 THAT THE SETTINGS WERE CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention