MAUDE Adverse Event Report: DJO LLC. CHATTANOOGA INTELECT LEGEND XT COMBOUS STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	2760
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Health professional: occupation: unknown.Device not received 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.
Event or Problem Description
It was reported that "it is believed to have received burns during electrical stimulation treatment.The unit reportedly ramped up intensity on its own." device not received 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 INTELECT LEGEND XT COMBOUS STD
• Common Device Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO LLC.; 1430 decision street; vista CA 92081
• MDR Report Key: 11634000
• Report Number: 9616086-2020-00031
• Device Sequence Number: 14326660
• Product Code: IMG
• UDI-Device Identifier: 00888912292740
• UDI-Public: 00888912292740
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2760
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 04/08/2021
• 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