BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2861715 · Received December 7, 2012

    Report

    Report Number
    1644487-2012-03237
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2012 IT WAS REPORTED THAT THE VNS PATIENT HAD 10-12 SEIZURES THAT MORNING, APPROXIMATELY 10 HEAD DROPS WITH LOSS OF ALL MUSCLE CONTROL WHICH WAS SOMETHING NEW, ONE FOCAL SEIZURE LASTING 3-4 MINUTES WHERE THE PATIENT COLLAPSED IN THE BATHROOM, AND ONE GRAND MAL LASTING 6 MINUTES. THE PATIENT CALLED 911 AND HAD SWIPED THE VNS MAGNET ABOUT 10 TIMES WHICH STOPPED THE FOCAL SEIZURE BUT NOT THE GRAND MAL SEIZURES. THE PATIENT WAS ALSO GIVEN 7.5MG DIASTAT AS HE DID NOT HAVE A 10MG PORTION AT THE HOUSE. THE PATIENT WAS NOTED TO HAVE BEEN ILL THE LAST 2-3 WEEKS WITH THE FLU AND THEN HAD VOMITING, BUT THE PATIENT STATED THAT THE LAST TIME HE WAS SICK WAS ON (B)(6) 2012 AND HE HAS NOT HAD ANY MISSED MEDICATIONS. THE PATIENT WAS NOW ALSO HAVING BRADYCARDIA. THE PHYSICIAN'S OFFICE LATER REPORTED THAT SINCE THE PATIENT WAS GIVEN DIASTAT DUE TO HIS INCREASE IN SEIZURES, THIS CAUSED THE BRADYCARDIA. DIASTAT CAUSED THE HEART RATE TO DROP; THE BRADYCARDIA WAS A SIDE EFFECT OF DIASTAT AND NOT RELATED TO VNS. ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN ARE UNDERWAY BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN THE MANUFACTURER'S CONSULTANT STATED THAT THE ONLY INFORMATION THAT THE PHYSICIAN¿S OFFICE WAS ABLE TO PROVIDE WAS THAT THE INCIDENT WAS ON (B)(6) 2012 AND THE PATIENT WAS GIVEN ATIVAN AND DIASTAT WHICH IS WHAT CAUSED THE BRADYCARDIA. THE BRADYCARDIA DIDN'T HAVE ANYTHING TO VNS; IT WAS DUE TO THE PATIENT'S MEDICATION - DIASTAT AND ATIVAN. THE PATIENT'S SETTINGS WERE NOTED TO BE OUTPUT=1MA/FREQUENCY=20HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=5MIN/MAGNET OUTPUT=1.5MA/MAGNET ON TIME=60SEC/MAGNET PULSE WIDTH=250USEC AND THEN THE PATIENT CAME BACK IN ON (B)(6) 2012 AND THEY INCREASED THE OUTPUT CURRENT TO 1.25MA AND MAGNET OUTPUT TO 1.5MA, THE REST OF THE SETTINGS STAYED SAME. THE OFFICE AGAIN REITERATED THAT THE EVENT DID NOT HAVE ANYTHING TO DO WITH VNS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3245

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other