MAUDE Adverse Event Report: GAIT MYOELECTRIC STIMULATOR II; GMES II

Model Number GMES II

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Rash (2033); Skin Irritation (2076)

Event Date 12/03/2013

Event Type  No Answer Provided  

Event Description

This pt with cerebral palsy is the first to enrolled in a study to assess the benefits of surface electrical stimulation to improve walking.Water based electrodes were used to conduct the current from the stimulator to the skin which caused her plantar flexor and dorsiflexor muscles to contract at the correct time to move the leg properly for walking efficiency.The stimulation was provided throughout the day (6-8 hrs) whenever the child was walking and turned off automatically when the child was inactive.The child had been wearing the stimulation system for 3 weeks when she came for her weekly monitoring according to the study protocol.A skin rash developed under both pads stimulating the plantar flexor muscles.The pads were removed and stimulation was discontinued.The principal investigator photographed the leg and notified the irb of this event.The irb committee determined the child should be removed from the study.Eventually, the study was suspended due to a total of 4 children who developed a similar skin irritation.The rash began to improve once the pads were removed and the stimulation was discontinued.Within 10 days, the skin returned to a healthy color.The redness resolved within 5 weeks.Dates of use: (b)(6) 2013.Diagnosis or reason for use: hemiplegia.Event abated after use stopped or dose reduced: yes.Facility: (b)(6).

• Brand Name: GAIT MYOELECTRIC STIMULATOR II
• Type of Device: GMES II
• MDR Report Key: 3757120
• MDR Text Key: 4484900
• Report Number: MW5035667
• Device Sequence Number: 1
• Product Code: MKD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: GMES II
• Device Catalogue Number: NONE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 25