BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 6553128 · Received May 8, 2017

    Report

    Report Number
    1644487-2017-03746
    Event Type
    Malfunction
    Date Received
    May 8, 2017
    Date of Event
    April 11, 2017
    Report Date
    June 30, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS LATER REPORTED BY THE NURSE THAT THE PATIENT DID NOT BEGIN TO EXPERIENCE THE LABORED BREATHING UNTIL THE SETTINGS WERE CHANGED TO AN OUTPUT CURRENT OF 2MA. IT WAS ALSO EXPLAINED THROUGH THE CONVERSATION THAT THE PATIENT HAD BEEN PROGRAMMED TO JUST 0.125MA BACK IN FEBRUARY AND WAS PROGRAMMED FROM 1MA TO 1.5MA JUST 2 WEEKS PRIOR TO BEING BUMPED UP TO 2MA. IT WAS EXPLAINED TO THE NURSE THAT WHEN PROGRAMMING THE PATIENT UP BY A HALF STEP AS OPPOSED TO JUST A QUARTER STEP, THEY WILL RECEIVED A "WARNING" MESSAGE STATING SO, BUT THAT IT DOES NOT INDICATE THERE IS ANYTHING WRONG WITH THE DEVICE. IT WAS ALSO EXPLAINED THAT SINCE THE PATIENT IS NEW TO VNS, THE FAST TITRATION MAY BE THE CAUSE OF THE LABORED BREATHING AND THEY COULD TRY GOING BACK DOWN IN SETTINGS A LITTLE AND GIVING THE PATIENT A COUPLE EXTRA WEEKS TO ACCLIMATE TO SETTINGS. IT WAS EXPLAINED BY THE NURSE THAT A DIFFERENT PHYSICIAN HAD RECOMMENDED THE SAME THING. THE NURSE STATED SHE WOULD PROVIDE THIS FEED BACK TO THE PHYSICIAN. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE PHYSICIAN SENT A FAX STATING THAT THE PATIENT'S LABORED BREATHING AND THE SHORTNESS OF BREATH WERE BOTH RELATED TO VNS. THE NEUROLOGIST OPTED TO LOWER THE PATIENT'S OUTPUT CURRENT IN AN ATTEMPT TO RESOLVE THE SYMPTOMS AND THE PATIENT WAS ABLE TO TOLERATE THE NEW SETTINGS.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED BY THE PHYSICIAN'S OFFICE THAT THEY HAD PERFORMED A VNS ADJUSTMENT AND RECEIVED THE MESSAGE "PROGRAMMED CURRENT NOT BEING DELIVERED". THE NURSE STATED DIAGNOSTICS WERE NOT PERFORMED, BUT SHE DID NOTE THAT NO HIGH IMPEDANCE MESSAGE WAS OBSERVED. IT WAS LATER REPORTED THE PATIENT BEGAN TO EXPERIENCE TACHYPNEA AND LABORED BREATHING AFTER THE OFFICE VISIT. IT WAS FIRST OCCURRING EVERY 5 MINUTES AND THEN IT WAS OCCURRING EVERY 20 MINUTES, SO THEY WERE UNABLE TO TELL IF IS WAS OCCURRING WITH VNS STIMULATION. THE DEVICE HISTORY RECORD FOR THE LEAD AND THE GENERATOR WERE REVIEWED AND IT WAS FOUND BOTH DEVICES HAD PASSED ALL TESTING PRIOR TO DISTRIBUTION. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333175 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS, INC. 106 203881

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention