BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3183001 · Received June 21, 2013

    Report

    Report Number
    1644487-2013-01884
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    November 19, 2012
    Report Date
    May 23, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS TEMPORARILY DISABLED ON (B)(6) 2012 DUE TO THE PATIENT EXPERIENCING COUGHING WITH STIMULATION AND CHEST PAIN. THE COUGHING WAS RESOLVED WITH THE DEVICE DISABLEMENT, BUT THE PATIENT CONTINUED TO EXPERIENCE THE CHEST PAIN, WHICH WAS FOUND TO BE RELATED TO TRAUMA FROM THE PATIENT¿S LARGE DOG JUMPING ON HIS CHEST. THE PATIENT¿S MOTHER LATER REQUESTED THAT THE DEVICE BE TURNED BACK ON AS THE PATIENT¿S DEPRESSION WAS INCREASING WITH THE LOSS OF THERAPY. IT WAS NOTED THAT THIS INCREASE WAS BELOW PRE-VNS BASELINE LEVELS. FOLLOW UP WITH THE CLINIC CONFIRMED THAT THE PATIENT STARTED TO HAVE AN INCREASE IN DEPRESSION WHICH LED TO SUICIDAL THOUGHTS DURING THIS TIME. PER THE PHYSICIAN, THE PATIENT'S INCREASE IN DEPRESSION AND SUBSEQUENT SUICIDALITY WAS BELIEVED TO BE RELATED TO THE LOSS OF THERAPY AS THE PATIENT WAS MEDICATION-FREE WHILE USING THE VNS. THE PATIENT WAS PUT BACK ON MEDICATIONS UNTIL THE VNS THERAPY COULD BE INCREASED BACK TO EFFICACIOUS LEVELS. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2013, THE PATIENT REPORTED THAT THE DEPRESSION HE HAD EXPERIENCED DURING THIS TIME HAD INCREASED FURTHER THAN WHAT WAS ORIGINALLY REPORTED. HE STATED THAT AFTER THE DEVICE WAS TURNED BACK ON HE BEGAN TO EXPERIENCE A COUGH AGAIN AND THE SETTINGS WERE DECREASED FROM THE PREVIOUS SETTINGS TO HELP WITH TOLERABILITY. IT WAS REPORTED THAT NO NEW MEDICATION CHANGES OR MEDICAL INTERVENTIONS TOOK PLACE PRIOR TO THE INCREASED DEPRESSION AND NO ADDITIONAL TRAUMA OR MANIPULATION WAS SUSPECTED. THE PATIENT ALSO STATED THAT HE COULD FEEL STIMULATION AT ONE POINT; HOWEVER, AT SOME UNKNOWN DATE, HE STOPPED BEING ABLE TO FEEL THE STIMULATION. ON (B)(6) 2013, THE PATIENT REPORTED THAT HIS DEPRESSION WAS ¿RAGING OUT OF CONTROL¿. A NURSE FROM THE CLINIC REPORTED THE DAY BEFORE THAT THE PATIENT¿S SETTINGS HAD CHANGED ABRUPTLY OVER THE PAST WEEK AND THEY WERE TRYING TO RULE OUT VNS PROBLEMS; HOWEVER, THEY WERE NOT SURE IF THE VNS WAS WORKING. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282521 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS 102 014460

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other