Ironically, Minnesota based Medtronic Inc. received approval from the Food and Drug Administration to market a new cervical device on the same day the government agency issued a Class 1 pacemaker recall, its most serious classification.
The June 11 announcement involves a relatively small subset of older pacemakers the company produced beginning in the late 1990s.According to a statement last month by Medtronic’s CEO, Bill Hawkins, most of the affected products were distributed overseas.
The concern with specific Kappa and Sigma type devices is the increased possibility for separation of bonded interconnect wires from the electronic circuit to other components, such as the battery. This could cause the pacemaker to fail or run out of battery power. The patient might experience an abnormal heart rate resulting in lightheadedness, fainting, or worst-case scenario, death.
After consulting with their Physician Quality Panel, Medtronic initially sent letters to physicians and patients beginning May 18 alerting them of the dilemma. It was concerned that possibly 37,000 older pacemakers could be defective. The notification recommended that:
–Physicians should consider device replacement for patients who are both pacemaker dependent and who have been implanted with a device in the affected subsets.
–Physicians should continue routine follow up in accordance with standard practice for those patients who are not pacemaker dependent.
As of June 12, more than 95 percent of physicians who were notified have confirmed receipt of the company’s letter, according to a Medtronic statement.
The suspect pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300. Patients with these models can contact Medtronic at 800 505-4636 or 800 551-5544 to determine if their pacemaker is part of this recall. The web site is: http://www.KappaSigma SNList.Medtronic.com.
It is important to note that over 1.7 million Kappa or Sigma pacemakers have been implanted in patients all over the world since 1997. Only 2 percent, roughly 21,000, are part of this recall. And..most of these devices have been in patients for five years or longer. Possibly, they could be close to optional replacement time.
However, Medtronic recommends removal for only those who rely on their pacemaker for daily survival since risk of surgical removal is often greater than leaving it in place.
Consult with your cardiologist to determine what is the best course of action for you.