BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4061353 · Received September 4, 2014

    Report

    Report Number
    1644487-2014-02221
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 8, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PATIENT¿S MOTHER THAT HIS VNS SETTING CHANGED AFTER GOING THROUGH A BODY SCANNER. THE PATIENT HAD BEEN KEPT THERE FOR A WHILE AND HAD BEEN ¿SWIPED¿ WITH THE SECURITY WAND MULTIPLE TIMES. WHEN THE PATIENT LEFT HIS VOICE HAD A CONSTANT ¿TRILL¿ BUT IT HAS BEEN MORE NORMAL. THE PATIENT NOW REPORTS THAT THEIR VOICE NO LONGER HAS A ¿TRILL¿ WHEN THEY SWIPE THEIR MAGNET. THE MOTHER LATER REPORTED THAT THE PATIENT¿S SIGNAL FREQUENCY WAS AT 15 HZ WHEN IT HAD PREVIOUSLY BEEN SET TO 20 HZ. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541073 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS INC 105 202623

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR