MAUDE Adverse Event Report: MYOLYN, INC. MYOCYCLE MC-2; FES CYCLE ERGOMETER

Model Number MC-2

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Limb Fracture (4518)

Event Date 12/21/2022

Event Type  Injury  

Event Description

Patient (pt) is a 75 year old woman with a history of muscle weakness and paralysis secondary to a spinal cord injury (sci) that occurred over 40 years ago, and she has been a full-time wheelchair user since her sci.Pt also has a history of osteoporosis, but she cannot say when she was diagnosed except that it was "years" ago, and she has not been monitoring or undergoing any treatment for her osteoporosis.The pt was also recently diagnosed with "club foot" caused by contractures resulting from non-weight bearing over many years.The pt had been using a device similar to the suspect device as part of clinical rehabilitation in prior years, but this other device failed 2 years ago, prompting the pt to pursue purchase of the suspect device.On (b)(6) 2022, pt was prescribed the suspect device by a licensed physician who reviewed the pt's medical history and the device indications and contraindications, and she began using the device at home on (b)(6) 2022 after remote training with a licensed physical therapist.The device is a wheelchair accessible stationary bike with integrated functional electrical stimulation (fes) for up to 10 muscle groups at once and pedaling assistance/resistance applied by an integrated electric motor."extreme osteoporosis" is a published contraindication for the device because its intended use requires active muscle contractions that could fracture extremely weak bones.Similarly, "severe contractures or extremely limited range of motion" is also a contraindication, as the lower extremity joints require adequate range of motion for proper cycling.On (b)(6) 2022, the pt used the device as usual and as intended and reported no device malfunctions, which was confirmed by review of device data uploaded via wi-fi to the manufacturer's remote server (workoutid 143454).The next day on (b)(6) 2022), the pt noticed swelling around the right ankle joint.The pt has no lower extremity sensation as a result of her sci, so she cannot say if or when any acute injury occurred that might have caused the ankle joint to swell (i.E., we cannot be sure whether the subject device caused or contributed to this injury or not).Device data shows that the pt did not exceed 5 watts of cycling power output during her last fes cycling session, so, if the injury occurred while using the device, it occurred under very light loads.On (b)(6) 2022, the pt went to the emergency room (er) because her ankle swelling had not subsided, and x-ray imaging of the right ankle revealed closed fractures of the right tibia and fibula.The er team casted the pt's lower leg (immobilizing the ankle), and the pt has indicated that she will not use the suspect device again until her fracture has healed and she has clearance from her physician.The suspect device connects to the pt's home wi-fi and reports utilization and performance data, including user settings, to the device manufacturer.The manufacturer has reviewed all of the available data from the pt's use and determined that the device did not malfunction during the event reported.The data shows that the fes parameters, settings, and even muscular response were similar to previous sessions.During subsequent follow-up, the pt agreed that the device did not malfunction.The manufacturer hypothesizes that the pt has been experiencing a gradual loss of bone mineral density in the distal tibia and fibula, which is well-documented in wheelchair users with neuromuscular impairment.This effect may be accelerated by post-menopausal osteoporosis.In other words, it appears the pt's bones have lost enough strength to fracture under a relatively small load (if the fracture occurred on the device, it occurred at less than 5 watts, while a beginner cyclist may average around 75-100 watts over an hour), even though that load is applied by the patient's own muscles.Similar events have been reported in the fes literature, though it is a highly improbable event.It may also be possible that the pt had already sustained some bone damage in the fracture region prior to using the device, which has been reported for similar patients with bone fractures occurring during use of robotic lower extremity exoskeletons.In this case, it is impossible to determine when the fracture occurred and whether or not the suspect device caused or contributed to the event because the patient has no lower extremity sensation and cannot recall any sensation of acute injury.The manufacturer is operating under the assumption that the suspect device may have caused or contributed to the event though there is no direct evidence of this available.

Manufacturer Narrative

This is an adverse event caused solely by the patient's condition and not by a device malfunction or inadequate labeling.The device labeling indicates that extreme osteoporosis is a contraindication.The patient has a history of osteoporosis that may have reached a level considered to be extreme, as the patient's bones fractured under a relatively small load.See also attached manufacturer's adverse event meeting minutes.

• Brand Name: MYOCYCLE MC-2
• Type of Device: FES CYCLE ERGOMETER
• Manufacturer (Section D): MYOLYN, INC.; 6931 nw 22nd st, ste a; gainesville FL 32653
• Manufacturer (Section G): MYOLYN, INC.; 6931 nw 22nd street, suite a; gainesville FL 32653 1231
• Manufacturer Contact: matthew bellman ; 6931 nw 22nd street, suite a; gainesville, FL 32653-1231 ; 3522049066
• MDR Report Key: 16203668
• MDR Text Key: 307670745
• Report Number: 3013503259-2023-00001
• Device Sequence Number: 1
• Product Code: GZI
• UDI-Device Identifier: 00861553000417
• UDI-Public: (01)00861553000417(11)220503
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MC-2
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White