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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient during her e-stim treatment, she received an unexpected and painful electrical shock.The tens unit was set up by a female physical therapy assistant.Electrodes were placed on her body/skin in the areas of her right and left trapeziums muscle and her right and lower back muscle.The first 8-10 minutes of her treatment felt similar to other treatments, where she felt occasional gentle electrical stimulation in the area of the electrodes.At one point during her therapy, she received a continuous and strong current/shock that was very painful.(b)(6) was unable to sit up and reach out for the machine to turn it off.After about one minute of the intense pain, she was finally able to sit up and turn off the tens unit that was sitting out of her reach.She then pushed the call button.The patient described the feeling of "significant jolting type shocks" and also described it as "one shock when it malfunctioned it continued to shock and make all my muscles contract like i was having a seizure before anyone got to me to turn if off".The malfunctioning tens unit caused the patient to experience a burn injury.Following her appointment, (b)(6) began having pain in her neck and upper back.She felt like a burn or sore or blister was forming on the right side of her neck/upper back/upper shoulder, soon after leaving the appointment.(b)(6) described a feeling as if her right side of her face and right ear were "on fire".Later in the day on (b)(6) 2022 the patient went to the emergency department at (b)(6).Her chief complaint was: "burn to r (right) shoulder that radiates to r (right) face and ear.Had a tens unit on at physical therapy that shorted out".She was diagnosed with a, "second-degree burn right neck, back, and left back region totally 1% body surface area".The skin area around the burn area was numb.General/trauma surgeon, dr noted two small areas of "likely deep partial-thickness or more likely full-thickness burns".The surgeon recommended she follow up for wound care monitoring.In the days/weeks following this incident, the patient noted significant muscle tightening in the side of her right face/neck/upper back/shoulder.This tightness let to stiffness and decreased joint mobility and a notable increase in the incidence of her migraine headaches.She continues to experience significant chronic fatigue and changes in her cognitive abilities and her emotional stability.Not only did she have more headaches following the tens unit burn, but the severity and frequency and duration of them worsened.
Additional Manufacturer Narrative
It was reported by the patient during her e-stim treatment, she received an unexpected and painful electrical shock.The tens unit was set up by a female physical therapy assistant.Electrodes were placed on her body/skin in the areas of her right and left trapeziums muscle and her right and lower back muscle.The first 8-10 minutes of her treatment felt similar to other treatments, where she felt occasional gentle electrical stimulation in the area of the electrodes.At one point during her therapy, she received a continuous and strong current/shock that was very painful.(b)(6) was unable to sit up and reach out for the machine to turn it off.After about one minute of the intense pain, she was finally able to sit up and turn off the tens unit that was sitting out of her reach.She then pushed the call button.The patient described the feeling of "significant jolting type shocks" and also described it as "one shock when it malfunctioned it continued to shock and make all my muscles contract like i was having a seizure before anyone got to me to turn if off".The malfunctioning tens unit caused the patient to experience a burn injury.Following her appointment, (b)(6) began having pain in her neck and upper back.She felt like a burn or sore or blister was forming on the right side of her neck/upper back/upper shoulder, soon after leaving the appointment.(b)(6) described a feeling as if her right side of her face and right ear were "on fire".Later in the day on (b)(6) 2022 the patient went to the emergency department at (b)(6).Her chief complaint was: "burn to r (right) shoulder that radiates to r (right) face and ear.Had a tens unit on at physical therapy that shorted out".She was diagnosed with a, "second-degree burn right neck, back, and left back region totally 1% body surface area".The skin area around the burn area was numb.General/trauma surgeon, dr noted two small areas of "likely deep partial-thickness or more likely full-thickness burns".The surgeon recommended she follow up for wound care monitoring.In the days/weeks following this incident, the patient noted significant muscle tightening in the side of her right face/neck/upper back/shoulder.This tightness let to stiffness and decreased joint mobility and a notable increase in the incidence of her migraine headaches.She continues to experience significant chronic fatigue and changes in her cognitive abilities and her emotional stability.Not only did she have more headaches following the tens unit burn, but the severity and frequency and duration of them worsened.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• 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: 19056512
• Report Number: 9616086-2024-00013
• Device Sequence Number: 12529989
• Product Code: IMG
• UDI-Device Identifier: 00888912292740
• UDI-Public: 00888912292740
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 04/06/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female