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FDA Issues Class I Recall of Deep Brain Stimulation Leads
By Joe Messa
Philadelphia medical malpractice lawyers advise patients that Medtronic has notified doctors of a complication with deep brain stimulation (DBS) leads that the company manufactures. Medtronic sent the notification to physicians in February after receiving “reports of DBS leads being damaged due to twisting of the connector within the lead cap during the surgical procedure.” The lead cap comes in the DBS lead kits and is included in dystonia therapy kits. The caps are also used temporarily on the end of a lead after the device has been implanted.
The US Food and Drug Administration is currently reviewing a manufacturing change that Medtronic says addresses the issue with the defective leads. In the meantime, the agency has recalled the defective leads.
Medtronic’s DBS leads have been classified as a Class I Recall by the FDA. Class I is the most serious type of recall that the FDA issues. It indicates that there is a reasonable risk of serious adverse events or death associated with use of the product. Physicians and DBS lead patients should be aware of the risks associated with Medtronic’s defective leads. Patients who have had the DBS leads implanted or those experiencing problems should consult their physician right away.
The Philadelphia medical malpractice lawyers at Messa & Associates are experienced at handling cases involving serious injuries or deaths as a result of defective medical devices, including DBS. Our extremely skilled team of medical malpractice attorneys and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you or a loved one has suffered an injury after using Medtronic’s Deep Brain Stimulation leads or another defective medical device, contact the medical malpractice lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More
