MAUDE Adverse Event Report: DJO LLC CHATTANOOGA; LEGEND XT 2CH STIM PKG

Catalog Number	2763
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that patient sustained 2nd degree burns under 3 electrodes during treatment that required medical treatment at urgent care the device has been returned and evaluated.The device passed all functional testing and is in good shape.Lead wires were tested and show good continuity.The root cause not properly preparing skin or using off brand accessories could cause burns under stim therapy.
Event or Problem Description
It was reported that patient sustained 2nd degree burns under 3 electrodes during treatment that required medical treatment at urgent care.

• Brand Name: CHATTANOOGA
• Common Device Name: LEGEND XT 2CH STIM PKG
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera lobre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245, mex 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 21915074
• Report Number: 9616086-2025-00043
• Device Sequence Number: 7109351
• Product Code: IMG
• UDI-Device Identifier: 00888912293013
• UDI-Public: 00888912293013
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K031077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2763
• Device Lot Number: T2687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 100 KG