BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3827885 · Received May 22, 2014

    Report

    Report Number
    1644487-2014-01350
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 28, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE WAS FINE AND THAT THERE WERE NO ISSUES. THE PATIENT¿S DEVICE SETTINGS WERE INCREASED AND THE INCREASED SETTINGS CAUSED THROAT PAIN AND VOICE ALTERATION. THE PATIENT COULD NOT TOLERATE THE HIGHER SETTINGS. THE SETTINGS WERE DECREASED AND THE PATIENT WAS DOING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS HAVING ISSUES INTERROGATING THE PATIENT¿S DEVICE. THE PHYSICIAN STATED THAT THE PATIENT LIKELY LEFT HIS OFFICE VISIT ON (B)(6) 2014 WITHOUT HAVING HIS DEVICE SETTINGS ADJUSTED. THE PATIENT WAS SCHEDULED TO HAVE HIS DEVICE SETTINGS LOWERED BECAUSE HE WAS HAVING DIFFICULTY TOLERATING STIMULATION. IT WAS REPORTED THAT THE PHYSICIAN HAD ISSUES INTERROGATING THE PATIENT¿S DEVICE IN THE PAST. THE WAND BATTERY WAS REPLACED AND CONFIRMED TO BE FUNCTIONING NORMALLY. THE PROGRAMMING SYSTEM WAS THEN ABLE TO INTERROGATE A DEMO DEVICE. IT WAS REPORTED THAT THE NURSE ALWAYS HAD THE PROGRAMMING SYSTEM WAS PLUGGED IN WHILE INTERROGATING PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305422 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202085

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR