$85 Million Premises Liability Verdict | Here goes a short description of the case (maybe the title) and a link to read more (optional)

FDA Issues Class I Recall of Deep Brain Stimulation Leads

new jersey personal injury attorneys | new jersey personal injury attorneys

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.

Medical Malpractice Lawyers Learn of FDA Class I Recall of Medtronic’s DBS 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.

Medical Malpractice Lawyers in Philadelphia and New Jersey

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.

About the Author

Joe Messa

Joe MessaJoe Messa is the founder of Messa & Associates, a results-oriented personal injury law firm comprised of New Jersey and Philadelphia attorneys who specialize in medical malpractice, product liability, catastrophic injury, motor vehicle accidents, brain injury, birth injury, and burns, fires, and explosions. Messa & Associates holds a distinguished record of multi-million dollar verdicts and settlements for catastrophically injured clients, including but certainly not limited to: a $120 million Products Liablity settlement, an $85 million Premises Liability verdict, a $35 million Work Injury settlement, a $28.7 million Motor Vehicle Accident verdict, and a $16.5 million Medical Malpractice verdict.View all posts by Joe Messa →

  1. Amy VelezAmy Velez04-15-2015

    I would like to meet with you regarding my cousin’s potential case against Johns Hopkins.

    My cousin Ken had an operation called “Deep Brain Stimulation” to improve his Parkinson’s symptons..during this operation, while he lay on the operating table in a semi-awake state, it was determined that the device was faulty.

    Dr. Frederick Lenz (Johns Hopkins Neurosurgeon) was unsure of the stability of the device, so he paged the Medtronic Rep to come into the OR. He also called the company’s hotline to ask a question about the device. In the OR report, Dr. Lenz states that Medtronic advised him to “just proceed” (his words in the report) with continuing to implant the device (the leads).

    Essentially, it was a “work around” since they did not have any other devices on hand. This caused damage and pain to my cousin and has resulted in the loss of his voice…not entirely, but he is really difficult to understand.

    I have all of his records….much more info to follow if you are interested in speaking about this sometime?

    Thanks, Amy

  2. Greg Van CampenGreg Van Campen06-01-2016

    April 29, 2011 DBS surgery – Medtronic 3387S Brain leads implanted (which were recalled by FDA) in Billings MT.
    May 1, 2016 suffered a stroke & focal edema
    May 2, 2016 returned to surgery for Intrarcranial hemorrhage
    May 26,2011 admitted to hospital for brain abcess
    May. 27,2011 surgery for brain abcess & to remove leads
    Spent four months twice a day IV therapy, Physicial Therapy and OT therapy

    Permantly disabled with memory loss, seizures, headaches, balance and congnative skills.
    We were never informed of a recall ever.

    • Greg Van CampenGreg Van Campen06-01-2016

      Sorry suffered stroke May 1,2011 and had surgery May 2, 2011 for intracranial hemorrhage.

      Thank you for your time

Leave a Reply

Philadelphia | Downingtown | Conshohocken | Cherry Hill | Collingswood | Linwood | Roselle