What We Do
Defective Medical Products
- Medtronic Defibrillator Leads
- Medtronic Lawsuit
- Medtronic Lawyer
- Guidant Recalls
- Free Guidant Recall Consultation
- Guidant Ancure
- Guidant Lawsuit Recall
- Guidant Pacemaker Defibrillator Defect
- Guidant Pacemaker Recall
- FDA Pacemaker Defibrillator Statement
- Infusion Pump
- Accutane Lawsuit
- AMO Complete Moistureplus Recall
- Apothecure Colchicine Lawsuit
- Baxter Heparin Recall and Lawsuit
- Bismacine Chromacine
- Botox
- Carbinoxamine
- Chromium Poisoning (Toxicity)
- Colchicine Recall Lawyer
- Colistimethate Lawsuit Lawyer
- Edetate Disodium
- Fentanyl
- Fentanyl Patch Recall
- Fentora
- Fleet Lawsuit - Phosphate Nephropathy Kidney Failure
- Fluoroquinolone Antibiotics
- Fosamax Osteonecrosis Jaw
- Ketek Liver Failure
- Ortho Evra Birth Control Patch
- Promethazine
- Rocephin Death
- Selenium Poisoning (Toxicity)
- Topical Anesthetic
- Total Body Formula Recall and Lawsuit
- Trasylol and Kidney Failure
- Trasylol - Lawyer and Lawsuit
- Trasylol Recall
- Tysabri Lawsuit - No Recall
- Tysabri Natalizumab
- Zelnorm Heart Attack Stroke Lawsuit
- Medicines
- Medical Equipment
- FDA Recalls
- News & Topics
- Archives
Welcome to Pritzker | Ruohonen
MEDTRONIC DEFIBRILLATOR LEAD RECALL: MEDTRONIC RECALL INFORMATION
Pritzker | Ruohonen is representing clients injured by defective Medtronic defibrillator leads. Two of our clients were shocked over twenty times before medical professionals were able to turn off the defibrillator.
If you are interested in being represented in a Medtronic lawsuit, please contact Pritzker | Ruohonen. The firm has a national reputation, and attorneys at the firm have been interviewed by The New York Times, The Wall Street Journal, Lawyers USA and other publications. In recognition of their achievements, Fred Pritzker and Rich Ruohonen have been selected as “Super Lawyers” by Law & Politics magazine. To contact the firm, please call toll-free at 1-888-377-8900 or submit the firm’s free case consultation form.
FDA Information Regarding the Medtronic Recall
Medtronic has removed its Sprint Fidelis defibrillator leads from the market because they may fracture, which can cause the defibrillator to deliver unnecessary shocks or not operate at all. This is considered a Medtronic recall. Some deaths, at least 5, and major complications have occurred after the leads have fractured.
A defibrillator lead connects the defibrillator, which is implanted near the shoulder, to the heart. If a lead fractures, it may send false signals to the defibrillator, causing the defibrillator to deliver unnecessary shocks or, in some cases, not to pace or shock when needed. Our clients have explained that the shocks are quite painful and that the fear of experiencing additional shocks is intense.
More than 268,000 recalled Medtronic leads were used with various defibrillators. Patients should consult their doctors regarding their defibrillator leads, and if a Sprint Fidelis defibrillator lead is involved, they should discuss what course of action to take. If you opt to have a recalled Medtronic defibrillator lead removed, contact a Medtronic lawyer at Pritzker | Ruohonen about a Medtronic lawsuit.
The FDA has provided the following explanation of the defect and recommendations regarding the Sprint Fidelis defibrillator leads:
Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire or lead that is connected to the heart.
When a defibrillator lead is slightly more prone to fracture, it doesn't mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.
Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don't know if this rate of adverse events will remain constant or increase over the life of these leads.
FDA considers Medtronic's action to be a product recall, as defined by FDA regulations, and we will soon be issuing a recall classification for this action. We recognize that some patients and health care professionals might inappropriately interpret the word "recall" to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed.
The leads continue to function properly in the vast proportion of patients. Although there is no test to predict which lead will fracture, FDA agrees with Medtronic's recommendation that defibrillator settings be adjusted at the patient's next scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed.
Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model.
Patients should recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients have reason to believe that they have a Sprint Fidelis lead or if they do not know the model of their lead, they should contact their health care professional.
FDA will continue to monitor information on these devices and will take whatever other actions may be necessary.Medtronic Defibrillator Lead Recall - Medtronic Recall - Medtronic ICD Lead Recall - Sprint Fidelis Lead Recall
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Firm News
Fred Pritzker Listed in The Best Lawyers in America
Fred Pritzker has been notified that he will again be listed in The Best Lawyers in America for his work in personal injury litigation.
Pain and Suffering
Rich Ruohonen recently chaired a legal seminar on obtaining compensation for pain and suffering in a personal injury case. Rich uses his knowledge, experience, and reputation to maximize recoveries for clients.
Medtronic Recall and Medtronic Lawsuit
FDA has annonced a Medtronic Spring Fidelis defibrillator lead recall. Two of our clients with defective Medtronic leads were shocked over twenty times before medical professionals were able to turn off the defibrillator.
Fleet Lawsuit
We are representing several people who experienced kidney failure (acute phosphate nephropathy) after use of Fleet Phospho-soda solution or Fleet Accu-Prep solution for bowel cleansing.
Ortho Evra Lawsuit: Ortho Evra Birth Control Patch
The Ortho Evra birth control patch has been linked to an increased risk of blood clots that can lead to pulmonary embolism, stroke and heart attack.
Trasylol Recall
Bayer has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.
Fentanyl Lawsuit and Fentanyl Recall
There have been a number of recalls regarding fentanyl due to the risk of a fentanyl overdose.
Fosamax and Osteonecrosis
Several cases of bisphosphonate-associated osteonecrosis of the jaw have been associated with the use of oral bisphosphonates, including Fosamax®, Actonel®, and other medications.