CIONIC NS-100Recalls & reported problems
Cionic, Inc. · Cionic Neural Sleeve NS-100 · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI G345NS1000), received between Jun 24, 2024 and Jun 24, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
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 STIMUL
Patient problems: Fall
MAUDE report 19601258 ↗
Other Stimulator, Neuromuscular, External Functional devices
- CHATTANOOGA 2761Djo, LLC · STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL7 reports
- MyoCycle MC-2Myolyn, LLC · Stimulator, Neuromuscular, External Functional2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.