InjuryGZI
NEURAL SLEEVE
Received Jan 2, 2025 · Event occurred Jun 17, 2023
Report MW5164260 · MDR key 21071146
Device
Generic name
Stimulator, Neuromuscular, External Functional
Manufacturer
Cionic FacilityModel number
NS-100Lot number
2023-08-01
Patient
55 YR · Female
- Erythema
- Hypersensitivity/Allergic reaction
- Superficial (First Degree) Burn
- Skin Inflammation/ Irritation
- Erythema
- Hypersensitivity/Allergic reaction
- Superficial (First Degree) Burn
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
I RECEIVED A CIONIC NEURAL SLEEVE IN (B)(6) 2023. THIS IS AN FDA APPROVED DEVICE THAT USES AI(ARTIFICIAL INTELLIGENCE) AND FUNCTIONAL ELECTRIC STIMULATION TO HELP ME WALK. ON (B)(6) 2023 THE BATTERY OVERHEATED AND BURNED ME. THE BATTERY WAS REPLACED BY THE COMPANY. IN (B)(6) 2024 I DEVELOPED A SEVERE ALLERGIC REACTION TO THE GEL PADS. THIS CAUSED MY SKIN TO TURN BRIGHT RED, FLAKY, AND ITCHY. MY SKIN WEPT. I HAVE BEEN UNABLE TO WEAR THE SLEEVE SINCE WITHOUT MY SKIN GETTING EXTREMELY NASTY.