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

Catalog Number	2763
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clinician reported a small burn on the patient after which this unit was promptly removed from service.Discovered the device had defective intensity encoder.Cracked lead-wires inlet.Broken control board to stim board ribbon cable connector.Defective lcd screen, dark, vertical line.Replaced parts.Cleaned up unit thoroughly inside and out.Conducted full functional test.Recommended for the customer to replace electrodes frequently with good quality ones.The root cause could was not established, poor condition of the electrodes the client was using could have contributed to the reported issue.
Event or Problem Description
The clinician reported a small burn on the patient after which this unit was promptly removed from service.

• 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: 21370553
• Report Number: 9616086-2025-00011
• Device Sequence Number: 8564460
• Product Code: IMG
• UDI-Device Identifier: 00888912293013
• UDI-Public: 00888912293013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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: 1219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 02/12/2025
• 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: Unknown