Medtronic Recall Medical Devices

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FDA ISSUES MEDTRONIC RECALL: October 17, 2007 10-17-2007

Audience: Cardiologists, emergency services personnel, risk managers, consumers
[UPDATED 10/17/2007] FDA issued a Class I Recall of Medtronic Inc. Sprint Fidelis Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007. Patients who are implanted with this lead, or do not know the model of their lead, should contact their physicians for further information.

NEWS: October 16, 2007 for Medtronic:

A defect was found in the electrical wire, known as the Sprint Fidelis, has resulted in many cases of malfunctions and may have been related in the death of five Medtronic defibrillator patients.

FDA News on Medtronic Sprint Fidelis defibrillation:

Medtronic has voluntarily suspend distribution of the Sprint Fidelis defibrillation leads because a small number of fractures have been detected. Because of Medtronic taking action in this, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company.

Four Sprint Fidelis Models Recalled: 6930, 6931, 6948, and 6949.

Use this link for more information from the FDA: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fidelis

-------------------end of Oct 16, 2007 update----------------

Recalled Defibrillators and Pacemakers

Recalled Pacemaker Models:

• Sigma 100S (Models SS103, SS106)
• Sigma 200D (Model SD203)
• Sigma 200DR (Model SDR203)
• Sigma 200S (Model SS203)
• Sigma 200SR (Model SSR203)
• Sigma 300D (Model SD303)
• Sigma 300DR (Models SDR303, SDR 306)
• Sigma 300S (Model SS303)
• Sigma 300SR (Models SSR303, SSR306)

Recalled Defibrillators or Combination Devices:

• 7230 Marquis VR
• 7274 Marquis DR
• 7232 Maximo VR
• 7278 Maximo DR
• 7277 InSync Marquis
• 7289 InSync II Marquis
• 7279 InSync III Marquis
• MicroJewell II Model 7223Cx
• Gem DR Model 7271

How Medtronic Defibrillators and Pacemakers Work

Medtronic defibrillators and pacemakers work by delivering a small jolt of electricity to your heart. They either pace the heart by helping it beat regularly and at a normal rate, or they shock your heart to stop a life-threatening irregular rhythm.

Medtronic defibrillators and pacemakers have two parts: a wire and a battery. The wire is attached to the heart muscle and carries the electrical jolt from the battery to the heart. The battery is usually implanted under the skin of the chest in a "pocket."

Most Medtronic defibrillators and pacemakers have to be replaced about every five years because the battery runs down. The patient's physician can detect when the battery is starting to get low during routine office visits.

The Problem with Medtronic Defibrillators and Pacemakers

Medtronic recalled about 28,000 pacemakers worldwide because the wire could separate from the battery. Most of the pacemakers prone to this problem had already been replaced because of normal battery depletion. About 6,650 people in the US still had these pacemakers in, and most were due to be replaced soon. No serious medical problems were reported due to this defect.

Medtronic also recalled about 87,000 defibrillators because of a problem with the battery. The battery would short out, and would run down very quickly and suddenly, causing the defibrillator to fail. At least one serious injury and four deaths happened because of this defect.

Nearly all the Medtronic defibrillators and pacemakers recalled were manufactured before 2003.

Signs and Symptoms

If your pacemaker or defibrillator fails, you could experience shortness of breath, dizziness, confusion, a very slow or very fast pulse, heart flutters, loss of consciousness or death.

Several people with Medtronic defibrillators and pacemakers that were defective noticed that their "pocket," where the device was implanted under the skin, was warm.

Some Medtronic defibrillators and pacemakers have a sort of "low battery alarm," which beeps if the battery gets too low. However, most of the defective batteries lost their charge so quickly that the alarm didn't go off.

If you experience symptoms or if you notice unusual warmth around your pacemaker, or if you hear beeping from your pacemaker, seek medical attention immediately.

If you have been injured because of defects in Medtronic defibrillators and pacemakers, you may be entitled to compensation for injury-related expenses and other costs.

Recalled Minimed Diabetic Infusion Sets

Recalled Infusion Set Model Numbers:

• MMT 359S6
• MMT 359S9
• MMT 359L6
• MMT 359L9

Insulin Pumps and Medtronic Minimed Diabetic Infusion Sets

People with diabetes use insulin pumps for two main reasons: because they don't have to endure as many pokes and shots as they do with insulin shots, and to maintain their blood sugar within narrow limits, without it getting either too high or too low.

Insulin pumps generally have two parts: the pump, which holds and delivers the insulin, and an infusion set, like the Medtronic Minimed Diabetic Infusion Set, which is inserted under the skin and connects to the infusion pump.

The Problem with Medtronic Minimed Diabetic Infusion Sets

In 2004, Medtronic released an updated version of their diabetic infusion sets, the Medtronic Minimed Diabetic Infusion Set. People who used the new set complained that it didn't work as well as the old one, and that they preferred the old set over the new one. Medtronic offered to replace any defective infusion sets, and gave them information to help them use the sets better.

Despite customer complaints, Medtronic discontinued the old infusion sets, forcing everyone to convert to the Medtronic Minimed Diabetic Infusion Sets listed above in the recall list. People continued to complain about the new infusion sets, and many felt that Medtronic was unresponsive to their complaints.

Finally, in May 2004, after several serious injuries and hospitalizations, Medtronic and the FDA issued a recall of the Medtronic Minimed Diabetic Infusion Sets. Medtronic asked its customers to stop using the sets immediately, and replaced them for free. They issued guidelines for how to manage their insulin if the patient had to wait for a new set to arrive.

There were several problems with the Medtronic Minimed Diabetic Infusion Sets that caused the flow of insulin to be interrupted. These included bent cannulas, tubing that got kinked and occluded, leaking around the insertion site and adhesive failure that allowed the tubing to get dislodged.

Patient Concerns Related to Medtronic Minimed Diabetic Infusion Sets

Failure of an insulin delivery system can cause wide fluctuations in blood sugar because the insulin is not being delivered correctly. If blood sugar gets too low, the person can go into insulin shock. If it gets too high, they can go into diabetic ketoacidosis. Failures caused by Medtronic Minimed Diabetic Infusion Sets are more likely to cause high blood sugars. In either case, if the person doesn't receive treatment to correct the blood sugar, he may lose consciousness and die.

There are also long-term consequences to fluctuating blood sugar levels. Long and/or recurring periods of very low blood sugar can cause brain damage.

A more subtle injury occurs with episodes of high blood sugar, which cause what is called "microvascular damage." This means that the tiniest blood vessels are damaged by episodes of high blood sugar. Eventually, this can cause damage to many parts of the body, including the eyes, kidneys, hands and feet, heart and other blood vessels.

If you have been injured because of a malfunctioning Medtronic Minimed Diabetic Infusion Set, you may have a right to financial compensation. If you used these infusion sets and think you may have been hurt because of it, calling a personal injury or medical malpractice lawyer could be your next step.

If you or someone you know was injured by any of these products, you may be entitled to financial compensation for your pain and suffering. Let our dedicated and experienced lawyers help you get the justice you deserve. Contact us today.

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