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

Model Number PDBT-915-2K

Device Problems Migration or Expulsion of Device (1395); Overheating of Device (1437); Charging Problem (2892)

Patient Problems Pain (1994); Numbness (2415); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 05/25/2020

Event Type  Injury  

Event Description

Hello, i had a stimwave implant put on about 8 months ago because of severe back pain after three surgeries.The trial did provide me pain relief.However, the permanent unit has not given me the same results.The representative only saw me two times and was unable to program the unit to work.After that he left me with a trainee.I reported malfunctions on the unit about two to four weeks after my surgery.One day when i put the unit on the tonic program where it vibrates i put the unit at option 18 and my stomach was jumping i could really see it jumping.I turned the unit down and reported the problem.After that i turned it down and when i turn it down my stomach didn't jump anymore, but the following day the program didn't work anymore.The vibration program stopped working.From that day i never got the therapy anymore and that option was helping me with the pain and my depression, when i had the trial it was actually giving me relief.Then after that i was told by the company's representative, that happened sometimes to other patients, and that was the end of that.I feel like the implant migrated when it jumped and that is causing me the numbness on my left arm.At other times the unit will make me feel electric shocks on my right leg and it will be like in certain positions when i was a standing up and i will bend down to put shoes on or pick up something, i will feel the electric shocks on my right leg.At another time i started to feel my arms get numbed when i raised them for more than three minutes.Then the electric shocks and pain on my left arm and hand.Again i was told it had nothing to do with the implant and to contact my doctor.I did and my pcp told me that the implant could be causing me the numbness on my arms after they told me to go see him.He did blood work to check for other causes.My hands get numb when i raise them ever since.To make matters worse the representative technician was promoted and a trainee was put in charge on my case and she's not very knowledgeable, but she knows how to say it's not related, contact your doctor.On 25 may i woke up with my numbness on my right leg and i couldn't walk right.I waited to see if it will pass it didn't, it just started to get worse and worse.Four hours later i contacted the pain management which is where the physician who did my implant works.I spoke to the doctor on call and he told me not to wait because of the implant on my spinal cord; i could be bleeding and he suggested me to go to the emergency room, so i went and told them what was happening.By that time my whole leg was numb and my left arm was also numb and giving me pain.The hospital did a ct-scan and an ekg and nothing abnormal came up.I was admitted into the hospital and the following day i had an mri and another ekg done and was told to wait.The second day when i needed to go to the bathroom my right foot would go inwards and i had to call nurse to help me to the bathroom.They put an alarm on my bed just so that they can make sure i didn't get up and fall.The third day the doctors couldn't see anything that would required surgery and told me that they didn't know what was causing my leg numbness and to contact the neurologist and surgeon for the implant.On the 27th i schedule an appointment with my neurologist doctor (b)(6).He examined me and i couldn't stand on my toes or my heels on the right leg.He then told me to contact my surgeon and tell them to take responsibility for what was happening to me.The technician in charge was promoted and he left a new trainee in charge of my case, almost three months after my surgery.Every time i reported a problem she would always say "it's not the unit contact your doctor".She told me she was going to reach out to the doctor for me but i never got a call.Two days after i called and no one had scheduled an appointment for me.I am seeing the doctor on the 15th of june to see if he knows why my leg is numb.I have contacted the company after i was unable to contact my technician by text or by phone.Sent an email and never received a response.They forwarded the email to the technician and they promised the technician that they were sending an engineer to reprogram the unit, but they didn't instead they sent him a formula.He couldn't get it to work and after that i never saw him again.Also the controls get very hot sometimes and the antenna moves around in the belt.Also the controls don't charge all the way.Please i need them to send me someone qualified to make sure the device didn't migrate which i have asked if that happened and they told me it didn't but they didn't show me the proof.Fda safety report id# (b)(4).

• Brand Name: FREEDOM STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INCORPORATED
• MDR Report Key: 10142756
• MDR Text Key: 194946175
• Report Number: MW5094934
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020150
• UDI-Public: 00818225020150
• 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: 06/09/2020

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: PDBT-915-2K
• Device Catalogue Number: PDBT-915-2A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Weight: 75