Medtronic Deep Brain Stimulation Leads May Be Damaged During Implant

Irvin Jackson

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Federal health officials are warning that problems with caps on Medtronic Deep Brain Stimulation (DBS) leads could cause severe injury or death.  

On May 2, the FDA classified a warning sent out by Medtronic regarding its Deep Brain Stimulation lead wires as a Class I medical device recall, suggesting that the agency believes problems with the lead caps are likely to result in severe injury or death. However, there have been no injuries reported to date.

The Urgent Medical Device Correction was originally sent out by Medtronic in February. According to the company, health care professionals have warned that DBS leads may be damaged due to twisting of the connector within the lead cap while a surgical procedure is underway. The caps are sometimes used to temporarily protect the end of a deep brain stimulation lead after it has been implanted, but not always.

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Spinal cord stimulator lawsuits are being investigated for individuals who suffered unnecessary shocks, burns or other problems, often resulting in the need for additional surgery to remove the SCS.

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Spinal-Cord-Stimulation-Lawsuit
Spinal-Cord-Stimulation-Lawsuit

Do You Know About…

Spinal Cord Stimulator lawsuits

Spinal cord stimulator lawsuits are being investigated for individuals who suffered unnecessary shocks, burns or other problems, often resulting in the need for additional surgery to remove the SCS.

Learn More
SEE IF YOU QUALIFY FOR COMPENSATION

Medtronic’s original communication stated that lead damage could result in the need for lead replacement or patients not getting the optimal DBS therapy. However, it did not warn of a risk of severe injury or death. The company says it has addressed the problem through a manufacturing change, which is now being reviewed by the FDA for approval.

Deep brain stimulation is similar to a pacemaker, but used in a patient’s brain. The leads deliver electrical pulses to precise locations in the brain to treat dystonia and Parkinson’s disease, as well as refractory epilepsy.

Medtronic advises customers who have experienced malfunctions or adverse events related to DBS therapy to contact the Medtronic Neuromodulation Technical Services at (800) 707-0933 and to also report the events to the FDA’s MedWatch Program.

Irvin Jackson
Written by: Irvin Jackson

Senior Legal Journalist & Contributing Editor

Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends.

Tags: Medtronic, Medtronic Recall, Parkinsons Disease

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4 Comments

Evelyn
My husband had a stroke in Oct. 2019. He had DBS surgery in March of 2012. He had lately been weak, falling, vomiting, had episodes of stroke like events. This Sunday was the worst. CT scans showed the electrodes in place, but dr. wonders if there was some damage with them because the stroke was in that part of the brain. I’m scared to have him cremated because we don’t know if the neurolostimulators could explode-or what could happen. Wondering if we should get an autopsy. Don’t have the money, but seeing this page makes me very concerned about the safety of these and that they could have had a part in his death. He passed away April 17, 2020 at 6:12 p.m. in the hospital.
Robert
My dbs wire fracture
Ron
possible lead poisoning and other complications my friend’s e-mail address is above enter phone number it’s okay to disclose thank you for your time
ch
thanks

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