BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    CIONIC NEURAL SLEEVE NS-100

    MDR report key: 19601258 · Received June 24, 2024

    Report

    Report Number
    3019892999-2024-00001
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    March 11, 2024
    Report Date
    May 28, 2024
    Manufacturer
    CIONIC INC
    Product Code
    GZI
    UDI-DI
    G345NS1000
    PMA / PMN Number
    K221823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESSON WHY THIS REPORT GOT SENT LATE IS BECAUSE WE INITIALLY MAILED THIS REPORT FIRST BY REGULAR MAIL AND THE SECOND TIME BY REGISTERED MAILD AND WE RECEIVED AN EMAIL BEING ASKED TO USE ESUBMITTER. THIS IS YOUR FIRST ELECTRONIC MDR SUBMISSION AND THE REPORT WAS DELAYED DUE TO THE SIGNUP PROCESS.

    Description of Event or Problem · 0

    THIS REPORT WAS MAILED ON 04/01/2024. THIS REPORT DETAILS THE INITIAL ONBOARDING SESSION FOR A CUSTOMER WHO PRESENTED WITH BILATERAL LOWER EXTREMITY WEAKNESS. THE INITIAL SETUP WAS FOR THE LEFT LEG PER STANDARD PROTOCOL TO ENABLE STIMULATION FOR ONE LEG AT A TIME. THE CUSTOMER SELF-SELECTED THE LEFT LEG FOR INITIAL SETUP AS SHE REPORTED THE LEFT LEG WAS WEAKER. THE MOBILITY SPECIALIST NOTED THAT THE CUSTOMER PRESENTED WITH LEFT HIP CIRCUMDUCTION, KNEE VALGUS, AND ANKLE INVERSION. THE PATIENT REPORTED A HISTORY OF FALLS WITH THE MOST RECENT ONE OCCURRING THE WEEK PRIOR. WHEN ASKED ABOUT PAIN, THE PATIENT REPORTED GENERALIZED PAIN THROUGHOUT HER BODY RATED AT 6-7/10 CONSISTENT WITH HER NORMAL, DAILY PAIN LEVELS. SHE DID NOT REPORT THAT PAIN IMPACTED HER WALKING. THE CUSTOMER WAS INITIALLY SITTING IN WHAT APPEARED TO BE A POWER WHEELCHAIR FOR THE SETUP OF STIMULATION. ALL FOUR MUSCLE GROUPS WERE ENABLED AT THE MOTOR OR SENSORY LEVEL PER THE FOLLOWING PARAMETERS: - SHIN STIMULATION TO ACHIEVE PROPER DORSIFLEXION WAS SET AT INTENSITY 50MA, 300 MICROSECONDS PULSE WIDTH, AND FREQUENCY 35HZ - CALF STIMULATION AT INTENSITY 35MA, 300 MICROSECONDS PULSE WIDTH, AND FREQUENCY 35HZ - QUAD STIMULATION AT INTENSITY 50MA, 300 MICROSECONDS PULSE WIDTH, AND FREQUENCY 35HZ - HAMSTRING STIMULATION INTENSITY 45MA, 300 MICROSECONDS PULSE WIDTH, AND FREQUENCY 35HZ THE CUSTOMER TOLERATED THE STIMULATION AND DID NOT REPORT ANY DISCOMFORT. THE CUSTOMER THEN STOOD UP USING HER BILATERAL PLATFORM WALKER. THE CUSTOMER'S HUSBAND WAS PRESENT THROUGH THE SESSION AND BEGAN FILMING THE CUSTOMER'S GAIT FROM APPROXIMATELY 8 FEET IN FRONT OF THE CUSTOMER. THE MOBILITY SPECIALIST SAW THE CUSTOMER TAKE ABOUT 10 TOTAL STEPS THROUGH A ROOM WITH AN UNOBSTRUCTED PATH. AT THAT TIME THE CUSTOMER'S HUSBAND STATED THAT HE OBSERVED IMPROVEMENTS IN HER GAIT INCLUDING IMPROVED DORSIFLEXION. THE CUSTOMER TOOK AN ADDITIONAL 4 STEPS AND THEN LET GO OF HER WALKER WITH HER LEFT HAND. THERE WAS NO INDICATION AS TO THE REASON SHE REMOVED HER LEFT HAND. THERE WAS NO INDICATION AS TO THE REASON SHE REMOVED HER LEFT HAND FROM HER WALKER, BUT IT APPEARED TO IMPACT HER BALANCE AND SHE LANDED ON THE GROUND ON HER LEFT SIDE. THE CUSTOMER THEN COMPLAINED OF LEFT HIP PAIN. THE MOBILITY SPECIALIST WAS ABLE TO OBSERVE THE CUSTOMER VIA VIDEO THROUGHOUT THIS TIME. THE SESSION WAS THEN DISCONTINUED AT THE HUSBAND'S REQUEST. HE STATED THAT HE WOULD CONTACT THE MOBILITY SPECIALIST LATER WITH AN UPDATE ON THE CUSTOMER. THE MOBILITY TEAM MANAGER WAS PROMPTLY INFORMED ABOUT THE INCIDENT TO ENSURE PROPER OVERSIGHT AND DETERMINE POTENTIAL NEXT STEPS. A COMPLAINT FORM WAS INITIATED, CAPTURING THE COMPLAINT NUMBER AND ESSENTIAL DETAILS FOR EASY REFERENCE. THE MOBILITY SPECIALIST SENT A FOLLOW UP EMAIL INQUIRING ABOUT THE CUSTOMER'S WELL-BEING. THE CUSTOMER OPTED TO CANCEL, MANAGEMENT WAS NOTIFIED, AND AN RMA (RETURN MERCHANDISE AUTHORIZATION) WAS CREATED TO FACILITATE THE CUSTOMER'S RETURN PROCESS. TO ASSIST THE CUSTOMER, WE EMAILED THEM A RETURN LABEL TO EXPEDITE THE ENGINEERING ANALYSIS. THE UNIT HAS NOT BEEN RETURNED TO CIONIC. THE ORIGINAL PRODUCT WAS RETURNED TO US ON APRIL 12, 2024 AT 10:17AM. WE CONCLUDED OUR REPORT ON 5/16/2024. REPORT CONCLUSION: THE UNIT AND ITS COMPONENTS PASSED ALL INSPECTIONS AND TESTS, PERFORMING AS INTENDED. ALL REPORTS, LOGS, AND PICTURES ARE SAVED UNDER REVISION CONTROL. THE UNIT AND COMPONENTS ARE TAGGED AND STORED FOR FUTURE USE (IF NEEDED). IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712045 CIONIC NEURAL SLEEVE NS-100 EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR GZI CIONIC INC NS-100 120123 G345NS1000

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| H BILATERAL PLATFORM WALKER.