Spinal Cord Stimulators An Analysis of the Adverse Events Reported to the Australian Therapeutic Goods Administration

Spinal Cord Stimulators

An Analysis of the Adverse Events Reported to the Australian Therapeutic Goods Administration

https://journals.lww.com/journalpatientsafety/abstract/9000/spinal_cord_stimulators__an_analysis_of_the.98907.aspx

Abstract

Background

Spinal cord stimulators are used to treat intractable pain. Placebo-controlled trials of spinal cord stimulators typically involve short-term treatment and follow-up, so long-term safety and efficacy are unclear.

Aim

The aim of the study was to describe the adverse events relating to spinal cord stimulators reported to the Therapeutic Goods Administration of Australia between July 2012 and January 2019.

Methods

Adverse events were coded by seriousness, severity, body system affected, type of event, action taken, and attribution of fault. Data on the number of stimulators implanted and removed were sourced from the Admitted Patient Care Minimum Data Set.

Results

Five hundred twenty adverse events were reported for spinal cord stimulators. Most events were rated as severe (79%) or life-threatening (13%). Device malfunction was the most common event (56.5%). The most common action taken in response to an adverse event was surgical intervention with or without antibiotics (80%). The ratio of removals to implants was 4 per every 10 implanted.

Conclusions

Spinal cords stimulators have the potential for serious harm, and each year in Australia, many are removed. In view of the low certainty evidence of their long-term safety and effectiveness, our results raise questions about their role in providing long-term management of intractable pain.

5 Responses

  1. Guess I am in the great minority…. mine has been installed for over 11 years. I had the battery replaced in 2021. I continue to receive benefits…I have been able to avoid all opioid drugs. No problem with the implant.

  2. We all “know” that these very expensive=$ for Dr.s devices are so much more effective than $15.00 worth of opioids a month for patients. I think a lot of patients are forced to try these devices in adherence to their pain management contracts. I had to go to a pain management practice after my family dr. retired. My family dr. handled my pain meds for years and I had never had a pain management contract. A patient must be open to any and all treatments suggested in managing their pain. Physical therapy is often recommended to pain patients which for some is monetarily out of their reach. I for instance have a copay of $45.00 per session at 3 times a week this could really add up quickly. Why do the easy most effective thing (medication) when harder less effective treatments are the norm.

  3. My cousin has psoriatic arthritis really bad and has intractable pain. She’s had several surgeries and 2 were spinal cord stimulators. She had both removed within of short of period of being implanted. I also heard many, many horror stories with these things. One guy had emergency surgery to remove it. So No thank you to any Dr suggesting one to me of them. Bad News withthose things. I can’t imagine having something that vibrates like a TENS unit in the spinal cord area 24/7.

    • I agree and I had one removed myself and still have it minus the wires and I thank God I’m not on the floor shaking like a fish. I was getting electrocuted they are nasty as the wire in your spine can move.

Leave a Reply to Donna R Cancel reply

%d bloggers like this: