MAUDE Adverse Event Report: CHATTANOOGA GROUP INTELECT LEGEND XT; ELECTRICAL NERVE OR MUSCLE STIMULATOR

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Discomfort (2330)

Event Date 06/14/2016

Event Type  Injury  

Event Description

I was being treated at a physical therapy office and had two electrodes put on my left hip area for trochanteric bursitis.After the stimulator machine was on for about one minute, i started getting very excruciating soreness in the treated area.Since it was on for only ten minutes, i did not make a connection with the severe burn that resulted.When my therapist came back in the room, the electrodes were removed and when the therapist went to massage the area, the therapist asked if i knew i had some type of pressure sore and did i have any itching, soreness or awareness of the "lesion" that was noticed.I went to my primary care doctor who referred me to a dermatologist.Today, (b)(6) 2016, the dermatologist said it had not healed at all and did a biopsy.I also had my physical med rehab doctor check it out and as soon as he saw the "lesion/sore/burn", he said i was burned by the electrode.To date, even though i was told it is not infected, i was given an antibiotic ointment to put on once a day.That did not work much at all, just a slight decrease in size of wound.At this point i do not know what to do or which doctor's advice i should listen to.I will most likely get the biopsy results in one week, and i will take it from there.My hip area is extremely sore, looks disgusting, and until it is healed, if ever, i cannot have any physical therapy for the original trochanteric bursitis.I do not believe the physical therapist made a report but possibly wrote something in my chart.I am afraid of the wound becoming infected and feel this should be reported in case the equipment malfunctioned or the electrodes were not properly connected.Please advise and thank you.

• Brand Name: INTELECT LEGEND XT
• Type of Device: ELECTRICAL NERVE OR MUSCLE STIMULATOR
• Manufacturer (Section D): CHATTANOOGA GROUP
• MDR Report Key: 5815105
• MDR Text Key: 50392086
• Report Number: MW5063589
• Device Sequence Number: 1
• Product Code: IMG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 66 YR
• Patient Weight: 109