MAUDE Adverse Event Report: DJO LLC. CHATTANOOGA LEGEND XT 2CH STIM PKG; STIMULATOR, MUSCLE, POWERED

Model Number	2763
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Lead(s), Burn(s) From (3161)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health care professional/occupation: unknown.No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Event or Problem Description
It was reported that a patient was burned on the lateral component of the right knee distal to the joint line while on ifc.The intensity level of the treatment was not documented within the reporter's notes, but the patient had indicated that the stimulation was "strong but comfortable." it was reported that the reporter was not sure which electrode pads were used for this treatment, but they were a size 2 x 2.The device has not been received by the manufacturer at this time.Manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

• Brand Name: CHATTANOOGA LEGEND XT 2CH STIM PKG
• Common Device Name: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): DJO LLC.; 1430 decision street; vista, ca
• MDR Report Key: 10178685
• Report Number: 9616086-2020-00021
• Device Sequence Number: 2625445
• Product Code: IPF
• UDI-Device Identifier: 00888912293013
• UDI-Public: 00888912293013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2020

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: No Information
• Device Model Number: 2763
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other