MAUDE Adverse Event Report: DJO, LLC COMPEX SP 6.0; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Model Number 2538660

Device Problem Product Quality Problem (1506)

Patient Problem Tinnitus (2103)

Event Date 03/11/2021

Event Type  Injury  

Event Description

I have an appointment scheduled for tomorrow ((b)(6) 2021) with a family physician to investigate progressively worsening tinnitus in the left ear -- which has been worsening over a course of one week).I have no pain which might otherwise suggest an infection or perforated eardrum.I am not yet aware of impacted earwax, but i have not inserted anything to my ear or wore earbuds for some time.I suspect the tinnitus may a symptom of hearing loss owing to damage to the ossicles or the cochlea, which may have been caused by vibrations i have been exposed to while using an electrical muscular stimulation (ems) unit.While i used the ems unit as instructed and intended, including following warnings / precautions which advise against placing electrodes above the neck, i noticed that intense vibrations or currents for some programs on the device would cause my jaw and neck to vibrate even when the electrodes were placed below the neck.I am concerned that these palpable vibrations -- at times, strong -- may have contributed to damage to the sensitive structure of the ossicles or, otherwise, to the cochlea.I have used the device almost daily but only in 2-3 week intervals for about a year.However, i did not place the electrodes over the trapezius region, shoulders and chest in every session.Please investigate if ems-induced vibrations of the jaw or head from referred or direct electrode use can cause such damage and progressively worsening hearing loss.Thank you.Fda safety report id # (b)(4).

• Brand Name: COMPEX SP 6.0
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): DJO, LLC
• MDR Report Key: 11561907
• MDR Text Key: 242287226
• Report Number: MW5100212
• Device Sequence Number: 1
• Product Code: NGX
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/19/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 2538660
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 75