MAUDE Adverse Event Report: CIONIC INC CIONIC NEURAL SLEEVE NS-100; EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR

Model Number	NS-100
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: CIONIC NEURAL SLEEVE NS-100
• Common Device Name: EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR
• Manufacturer (Section D): CIONIC INC; 1500 green hills road; suite 109; scotts valley CA 95066
• Manufacturer Contact: mihai ionescu ; 1500 green hills road; suite 109; scotts valley, CA 95066 ; 8318244051
• MDR Report Key: 19601258
• Report Number: 3019892999-2024-00001
• Device Sequence Number: 15474913
• Product Code: GZI
• UDI-Device Identifier: G345NS1000
• UDI-Public: +G345NS1000/$$7120123
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221823
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 05/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: NS-100
• Device Catalogue Number: CIONIC NS-100
• Device Lot Number: 120123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BILATERAL PLATFORM WALKER.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White