MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES, INC. STIMWAVE; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) STIMWAVE TECHNOLOGIES, INC.

Model Number MD0847

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Visual Disturbances (2140); Palpitations (2467); Shaking/Tremors (2515); Shock from Patient Lead(s) (3162)

Event Date 01/15/2020

Event Type  Injury  

Event Description

I had a stimwave spinal stimulator trial.Wires were implanted into my back on monday, (b)(6) 2020.At 4:20am on (b)(6) i was awoken by a sharp shock.I contacted the tech and she told me to change the setting to the 3rd program.At 4:20 pm on (b)(6) 2020 received a severe shock from the stimulator.The shock was so severe i was jerking around, my heart was pounding and i couldn't see.I tried to remove to turn the stim off but couldn't.After the shock stopped a few seconds later i immediately turned the stim off and removed the control unit.I was shaking, my heart was racing.I was hurting everywhere and very scared.I called the tech and had to leave a message.I also text her stating that i wanted the stim removed immediately.I then called the pain clinic.(b)(6), told then what happened and arranged to have the stim removed as soon as possible.The tech, (b)(6) texted and called me later that evening.She tried to take me into allowing them to adjust the stim and down played the fact i was shocked.She did admit that other pts had complained about occasional "jolts." i refused and told her that i wanted the stim removed.On (b)(6) 2020, i had to drive to (b)(6) office (3 hrs on-way) to have the stim removed.The tech met me at (b)(6) at 11:15 am.The dr took pictures of the wires placement in my back.Then removed the wires from my back.The dr did not deaden my back or give me anything for pain relief before removing the wires with great difficulty from my back.The pain was almost unbearable.After the removal, she placed two bandaids over the cuts and give me several alcohol pads.I left the stimwave and all it's parts and info with the tech.She told me she would report what had happened and have the unit tested.I requested that she let me know what she found out.Because of this i almost died.I believe the shock was severe enough that it could have killed me.In addition i missed two days of work and have endured unbearable pain.My leg and back pain is even worse than before and i still have the pain from where the wires were in my back.This spinal stimulator needs to be banned until they can assure that people won't be harmed or killed i have pictures of the stimwave unit and a photo of the x-ray showing the placement of the wires in my back.Do you have a picture of the product? yes.Fda safety report id# (b)(4).

• Brand Name: STIMWAVE
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) STIMWAVE TECHNOLOGIES, INC.
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES, INC.
• MDR Report Key: 9621863
• MDR Text Key: 176385731
• Report Number: MW5092416
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MD0847
• Device Lot Number: 00264
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 66 YR
• Patient Weight: 77