Medtronic Pacemaker Recall
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On June 11, 2009, the U.S. Food and Drug Administration (FDA) issued a Class 1 recall of two types of Medtronic pacemakers that have been shown to malfunction. A Class 1 recall means that the use of this product with its faulty parts could have serious side effects and could even result in death.
The pacemakers from Medtronic are being recalled because there is a possibility they may not perform when needed. The company has discovered that wires that connect to the battery of the recalled pacemakers have been separating from the electronic circuit causing it to not perform properly or not at all.
Pacemakers are used by patients who suffer from abnormal heart beats and the device is used to regulate the rhythm to a healthy level. When the pacemaker does not perform properly, the patient may find that the original symptoms of an irregular heart rate return such as feeling light headed and or fainting. Serious injuries can occur and the malfunction can even result in death.
The Medtronic pacemakers that are being recalled are the Kappa Series models 600, 700 and 900, and the Sigma Series models 100, 200 and 300. The company has produced over 1.7 million Sigma and Kappa pacemakers that have been implanted in heart patients around the world. Of this the number of recalled pacemakers is around 21,000.
Many of the recalled devices were implanted in patients over five years ago. If you think that you have a Sigma or Kappa pacemaker that has been recalled you should contact your physician or healthcare professional immediately to prevent any serious repercussions.
The medical community was notified of the recall in early May and in turn physicians and health care professionals began notifying their patients. Being unaware of this recall could give a heart patient a false sense of security in feeling that their heart condition is under control.
The FDA constantly monitors medical devices to ensure the safety of the public and has set a standard of reporting requirements that is ongoing. Once the FDA becomes aware of a problem with a medical device it works closely with the manufacturer to ensure a safe and comprehensive recall.
Cardiac pacemakers are among the number of medical breakthroughs that have been developed over the past few years that help heart patients deal with their conditions in a safer manner. A pacemaker is implanted into a cardiac patient and it monitors the heart rate through electrical impulses and sends electrical stimuli to bring it back to a normal rhythm if it beats too slowly or an abnormal rate is detected.
If you think that you may have a recalled Medtronic pacemaker you should contact your physician and also the Medtronic Company. The company’s toll free number is 1-800-505-4636. If you have a recalled pacemaker from Medtronic and suffered from any side effects as a result of this defect, you should give our legal team at Napoli, Bern Ripka a call at 1-888-LAW-IN-NY to schedule a free consultation. Our lawyers are well versed in recalled medical products and can suggest a reasonable course of action.