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

Model Number	2760
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the the unit allegedly caused a shock to patient during stim treatment.The device could not be evaluated because it will not turn on.Device is new and will be replaced under warranty.No safety evaluation will be performed.
Event or Problem Description
It was reported that the the unit allegedly caused a shock to patient during stim treatment.

• Brand Name: INTELECT LEGEND XT COMBOUS STD
• Common Device Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• 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 libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 14718234
• Report Number: 9616086-2022-00015
• Device Sequence Number: 2379986
• Product Code: IMG
• UDI-Device Identifier: 00888912292740
• UDI-Public: 00888912292740
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown