MAUDE Adverse Event Report: DJO LLC LEGEND XT 4CH STIM PKG US STD; STIMULATOR, MUSCLE, POWERED

Model Number	2786
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device allegedly experienced an error code, burned a patient and the unit shuts off during treatment.
Additional Manufacturer Narrative
It was reported that the device allegedly experienced an error code, burned a patient and the unit shuts off during treatment.Djo performed an inspection on the actual device returned.The unit passed functional testing.The leadwires tested within tolerance and a new leadwire kit will be sent to the customer.The electrodes were non-djo electrodes.The foam electrodes were in bad shape, and both the foam and cloth electrodes were not very sticky.Large variance in resistance of the electrodes may have contributed to the incident.

• Brand Name: LEGEND XT 4CH STIM PKG US STD
• Common Device Name: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; suite 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; carlsbad; vista, CA 92010 ; 5128346301
• MDR Report Key: 13198893
• Report Number: 9616086-2022-00001
• Device Sequence Number: 1686743
• Product Code: IPF
• UDI-Device Identifier: 00888912294140
• UDI-Public: 00888912294140
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2022

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 Model Number: 2786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 01/07/2022
• 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