INTELECT LEGEND XT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-19 for INTELECT LEGEND XT manufactured by Chattanooga Group.

Event Text Entries

[50392086] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5063589
MDR Report Key5815105
Date Received2016-07-19
Date of Report2016-07-19
Date of Event2016-06-14
Date Added to Maude2016-07-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameINTELECT LEGEND XT
Generic NameELECTRICAL NERVE OR MUSCLE STIMULATOR
Product CodeIMG
Date Received2016-07-19
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCHATTANOOGA GROUP


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2016-07-19

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