BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2061986 · Received April 6, 2011

    Report

    Report Number
    1644487-2011-00705
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    July 28, 2010
    Report Date
    March 7, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN A PATIENT'S CLINIC NOTES THAT ON (B)(6) 2010, THE PATIENT'S SETTINGS WERE 1 MA/25 HZ/250 MICROSEC/14 SEC/3 MIN. THE DOCTOR NOTED THAT THE PATIENT'S VNS CURRENT WAS "INCREASED BACK TO 1.25 MA. HOWEVER, WHEN THE SYSTEM WAS REPROGRAMMED THE DEFAULT SETTINGS WERE RESTORED AND THE PULSE WIDTH JUMPED TO 500. [THE PATIENT] RECEIVED ONE STIMULATION AT THIS CURRENT STRENGTH AND WIDTH AND HAD SIGNIFICANT SYMPTOMS. HE HAD PAIN IN HIS NECK AND PAIN IN HIS HEAD. HE COUGHED AND HAD DIFFICULTY CATCHING HIS BREATH DURING THE COUGHING. THE DEVICE WAS IMMEDIATELY INTERROGATED AGAIN AND THE SETTINGS WERE RETURNED TO THE PREVIOUS SETTINGS AND HE TOLERATED THAT WELL. THE DEVICE WAS AGAIN INTERROGATED TO ASSURE THAT IT HAD RETURNED TO ITS TYPICAL SETTINGS. [HE] RECOVERED FROM THE STRONG STIMULUS AND WAS AGAIN HIMSELF WITHIN MOMENTS." GOOD FAITH ATTEMPTS TO GAIN MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200693

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR