FDA Issues Class I Recall of Deep Brain Stimulation Leads

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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.


Call the Philadelphia personal injury lawyers of Messa & Associates today to discuss your case with a professional who has the knowledge to answer your questions or submit a free online inquiry.

Call, toll-free, 1-877-MessaLaw (637-7252), or submit a free online inquiry form.

About the Author:

Director of Marketing for Messa & Associates located in Philadelphia, Pennsylvania. For all marketing or press release communications, contact sking@messalaw.com.

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  1. 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. 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.

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

      Thank you for your time

  3. In Feb. 2001 my husband James Russell had DBS procedure to control Parkinson’s tremor. The procedure was done at Methodist hospital in Houston by Dr. Simmons. On Jan. 1st 2013 a leadwire on the left side of his neck broke through the skin and Dr. Vardeman, a neurosurgeon at Methodist hospital in San Antonio had to remove the DBS system from his brain, the lead wire, and battery pack. Due to the break in the skin my husband developed an MRSA infection that prolonged his recovery and hospital stay. Since then James has had intermittent and severe reoccurrences of MRSA infections that started as tropical lesions of the skin, he had C-diff in Oct. – Nov. 2016 (resulting in a 6 week hospital stay). In Jan. of 2017 he began having unexplained severe lower back pain and he was diagnosed with Osteomeyelitis of spine and infection in surrounding back tissue resulting in a hospital stay from May 25 – Ausust 2017. He was hospitalized 2 more times with infection in discs and back tissue – the last time was Nov – Dec. 2018. Hospital stays were at St. Luke’s, Methodist, and University in San Antonio. In between reoccurences of spine infection, James started having STAPH resistant MSRA UTIs that caused sepsis; the last hospital stay for that was Aug. 2019. The severe infections and many months of IV antibiotics have taken a huge toll on James. He went from living at home, walking with a Walker and having Medicaid in home assistance to being admitted full time to a skilled nursing and long term care facility that started with the hospitslization in May 2017 to the present. Since the hospital stay in Sept. 2018 James has lost the use of his left leg and he has been wheel chair bound. Each hospital stay impacted James cognitively as well due

  4. Hello my name is Matthew Monfore (26 from Oral, SD…..a very, very rural place 🙂 ).

    1. My dad had DBS (deep brain stimulation- bilateral by medtronic) for so-called Parkinsons (I say that because parkinsons seems to be so broadly defined), which was taken out in April of this year (2020) because he had an infection in the chest implant (similar to pace maker)

    2. my dad has suffered catastophic, life-altering effects, worse than his Parkinons- speech, concentration, gait, problem solving, eyelid impairment , nightmares in REM sleep disorder with shouting and movement, hallucinations) And my dad has needed full-time care from our family -we don’t trust the doctors or nurses…

    3. I know DBS is involved because he was not like this before (his main problem mainly being left arm and leg movement problems), and his debiliitation would be on record in doctor, nurse visits. He is not on any other medicines–except for multivitamin and senna for constipation

    4. DBS itself is known to cause problems according to doctors

    A . mental side effects- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4837159/

    B. physical problems- https://www.neurologyadvisor.com/advisor-channels/movement-disorders-advisor/weighing-the-risks-of-deep-brain-stimulation/#:~:text=An%20individual%20who%20has%20undergone,the%20aftermath%20of%20DBS%20surgery.

    5. We were told by doctors AT the U of Colorado that they would not remove the DBS because it was not the problem for at least5 years( since 2015)! prior to April of this year (2020) where the doctor/and or resident with U of Minnesota who removed the device at the VA hospital in Minneapolis confirmed he knows DBS causes problems and that they dont even use medtronic or the particular device anymore (they are now focusing on -shielding systems with new Dbs devices—because they know there are problems)

    6.We would like compensation and justice so that this doen’t happen to someone else, as my research of the subject seems to indicate that we are not alone—medtronic says “It works! its reversible!” while it took a miracle – infection in his chest device to get it removed and provide us with evidence that the DBS was causing a lot o f what occurred…as my dad now seems to be improving in areas,..but it is slow

  5. In 2014 I had a Medtronics DBS system implanted in my brain for essential tremors. It worked fin foabout 5 years with adjustments every few months. In October of 2019 I had the battery replaced and after that I had numerous shocks and wound up in emergency with stroke like symptoms. The neurologist tried programming it numerous times with no success. In July of 2020 they did exploritory surgery and found corroded leads in my neck.
    In Sept. of 2020 they removed every thing and installed the St,Judes/Abbott DBS system. They found the leads in my brain were corroded also.

    Please respond
    Tom Hofstra

    1. I had the Activa DBS implanted bi-laterally for ET in Jan/Mar 2013. I have had no problems until April 2020. I started having shocks and stroke like symptoms. After having the extension wire replaced and continued problems, they were able to download info from the newest Medtronic/Activa device and saw that the problems are in the lead itself. I will be having surgery in the next 2 mos to replace left brain lead.

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