Medtronic Sprint Fidelis Leads Recalled

 

In this section:

• Medtronic Products
• Medtronic Safety Warnings
• Medtronic FDA Recall

Latest Medtronic News

Medtronic Inc. Recalls Defective Pacemakers

Medtronic Incorporation has warned physicians to cease using their pacemakers after they discovered faulty wiring in some models. The company believes the defect in the pacemakers’ wiring causes premature battery depletion, leading to slowed response time and eventual battery loss. Medtronic Inc. has already received two reports of death caused by their defective pacemakers.

Medtronic Inc. is urging physicians to remove the affected pacemakers from patients implanted with the defective lots, as well as encouraging patients with affected pacemakers to immediately contact their doctors for replacement.

The company estimates approximately 1.7 million pacemakers have been implanted since 1997. Medtronic believes more than 37,000 pacemakers are defective, with most of them having been shipped overseas.

Medtronic Warning Classified as Recall – Update 9.30.08

Medtronic has announced a recall of a medical device used in the treatment of patients with cystic fibrosis, traumatic brain injury and multiple sclerosis following a safety advisory related to Medtronic sutureless catheters. The Class 1 recall was issued after one patient died as a result of a failed catheter connection. A second patient died following surgery to replace a catheter, but the death has been ruled unrelated to the recall.

The Medtronic catheters are used in combination with implantable drug pumps to deliver infused drugs. The safety alert issued by Medtronic referenced 83 cases of catheter connection failure. In some instances, the catheter became blocked up, while in others, it became disconnected from the drug pump altogether. Faulty connections between implantable drug pumps and catheters can result in a fatal overdose.

Although a recall has been issued for the Medtronic device, the FDA is telling patients that replacement is not necessarily required. Rather, it is recommended that patients consult with their doctor to evaluate the best course of action. Since May 2007, Medtronic estimates that approximately 25,000 patients have been implanted with a Medtronic drug pump and sutureless catheter.

Update 10.05.07

On October 15th, 2007, Medtronic issued a release suspending all sales of Sprint Fidelis leads. The electrical wire, which is integral in pacemaker functionality, has been recalled because of a reported defect that is potentially fatal to those implanted with the device. The wire is designed to serve as the bridge between a person’s heart and an implanted defibrillator.

In addition to suspending sales of all Sprint Fidelis leads, Medtronic are urging patients who have already been implanted with the lead to consult with their physician and have the potentially-faulty lead surgically removed. It is roughly estimated that as many as 235,000 patients around the world are implanted with the recalled Sprint Fidelis lead.

Sprint Fidelis leads marketed by Medtronic under the model numbers: the 6949 LFJ extendable/retractable screw fixation (S) model; the 6948 LFH tuned fixation (T) model; the 6931 LFT S fixation; and the 6930 LFK T fixation.

Sprint Fidelis Lead Defect

The defective Sprint Fidelis lead is believed responsible for as many as five deaths that have been reported in conjunction with patients implanted with the wire. In many cases, the wire spontaneously fractures, releasing a large electrical shock that can be extremely painful and potentially fatal.

Medtronic representatives have stated that they believe the defect to be a very low risk threat for Sprint Fidelis patients. However, in the wake of recent pacemaker recalls issued by Medtronic and Guidant, the Minneapolis-based company is attempting to handle the situation in a conservative manner that ensures public awareness. Unfortunately, this move does little to lessen the pain of those already victimized by the defect.

Sprint Fidelis Lawsuits

If you or a loved one has been injured as a result of a defective Sprint Fidelis lead, you may be entitled to receive compensation for your pain, suffering, and medical costs. Medical device manufacturers are responsible for ensuring the safety and efficacy of their products before they are marketed. Failure to adequately measure and react to defective products is viewed as negligent and grounds for legal action.

The law offices of Aylstock, Witkin, Kreis, and Overholtz, boasts a dedicated team of professionals and some of the most experienced personal injury lawyers Pensacola, Florida has to offer. Contact AWKO LAW today at (877) 810 4808 to discuss your options as a Sprint Fidelis lead victim.