FDA Recall - Defective Medtronic Pacemakers
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An FDA recall was issued for certain Medtronic Sigma Series pacemakers on November 29th, 2005. Medtronic Sigma Series pacemakers have had problems with the wiring that connects the main circuitry of the pacemaker to the device header. This defect has proven capable of causing the device to fail, leading to the issuing of a class 1 FDA recall.
Heart disease is the leading cause of death in the United States, accounting for an estimated 200,000 to 400,000 deaths each year. Cardiovascular medical devices, such as the pacemakers and implantable cardioverter defibrillators that are manufactured by Medtronic, are used to treat patients suffering from heart rate/rhythm abnormalities resulting from some type of heart trauma.
The November 29th FDA recall was the latest class 1 recall to effect Medtronic Inc., one of the largest manufacturers of cardiovascular medical devices in the world. On April 4th, 2004, a class 1 FDA recall was issued for Medtronic's Micro Jewell II and GEM DR implantable cardioverter defibrillators (ICDs). It was discovered that some of the Medtronic ICD devices had defects related to the high voltage capacitors responsible for charging the battery in between shock therapy treatments. Delays in battery charging were judged capable of causing a delay in delivery or a "non-delivery" of electric shock treatment to a patient suffering from ventricular tachycardia (rapid heart beat) or ventricular fibrillation (irregular heart beat).
Medtronic has recommended that patients who have been implanted with the defective Medtronic pacemaker devices consult with their doctor immediately so as to devise the best course-of-action. Replacement of an ICD poses a certain degree of risk as it involves an invasive surgery; as such, replacement should be considered only if judged necessary by a patient's doctor.
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.
Food and Drug Administration - A Brief Introduction
The FDA is responsible for ensuring that a variety of products, spanning an array of markets are safe for public use/consumption. The FDA's responsibilities include ensuring that:
- Foods are safe, wholesome and sanitary.
- Human/veterinary drugs, biological products and medical devices (like Medtronic Pacemakers) are safe and effective.
- Cosmetics are safe.
- Electronic products capable of emitting radiation are safe.
In addition to regulation of the products themselves, the FDA is also involved in regulating the marketing of products following their approval in order to ensure that they are represented to the public in an informative, honest and accurate manner.
An FDA recall is typically a recommendation as opposed to an "order." The Federal Food, Drug, and Cosmetic Act does not authorize the FDA to order a recall unless a medical device, human tissue product or type of infant formula poses a risk to human health; under such circumstances, an FDA recall can be ordered. The FDA often requests a recall of a dangerous product if a manufacturer demonstrates an unwillingness to remove it themselves.
An FDA recall is classed based on the danger associated with the product in question:
- FDA Recall - Class 1: A class 1 FDA recall is the most serious type of recall. If a product is believed to have a "reasonable probability" of causing serious personal injury or death, the FDA can issue a class 1 recall.
- FDA Recall - Class 2: A class 2 FDA recall involves products that are believed capable of causing temporary health problems with minimal risk of serious injury.
- FDA Recall - Class 3: A class 3 FDA recall is the least severe of the three, involving products that are unlikely to cause health problems or injury, but violate certain FDA manufacturing or labeling regulations.
The law offices of Aylstock, Witkin, Kreis & Overholtz have a great deal of experience in litigation associated with personal injuries incurred as a result of defective medical devices like Medtronic pacemakers. If you or a loved one has been injured by a defective medical device (Medtronic pacemaker, ICD or CRT), the defective medical device lawyers of Aylstock, Witkin, Kreis & Overholtz are waiting to hear from you to discuss all available legal recourse.