Medtronic Pacemaker Sigma Kappa Side Effects. If you have a Medtronic Kappa or Sigma pacemaker, and have experienced symptoms associated with abnormal heart rate, such as fainting or lightheadedness, your device may be defective.
In June 2009, Medtronic Inc. issued an urgent recall of certain Kappa and Sigma pacemakers because of wiring problems that could cause the devices to fail. Our Medtronic pacemaker recall lawyers are currently offering free case evaluations to victims of these defective devices.
Thousands of people are currently implanted with one of these Medtronic pacemakers, and there is no way to detect a problem before the device actually fails. The trauma caused by faulty Kappa and Sigma pacemakers is immeasurable. People with one of the recalled Medtronic pacemakers are at a high risk of serious injury and even death.
Medtronic Inc. must be held accountable for the pain and suffering caused by its defective pacemakers. If you or someone you love was injured by one of Medtronic’s faulty Kappa or Sigma pacemakers, you may be entitled to compensation. Please contact one of our Medtronic pacemaker recall lawyers right away to protect your legal rights.
Medtronic Kappa and Sigma Pacemaker Recall
In June 2009, the Food & Drug Administration (FDA) announced a Class I recall of several models of Kappa and Sigma pacemakers manufactured by Medtronic Inc. A Class I recall is the agency’s most serious type of recall action, and is issued when there is a high probability that a defective device will cause serious injury or death.
The Kappa and Sigma pacemaker recall was issued because the devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.
Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death.
The Medtronic pacemaker recall involved roughly 21,000 devices. Most of the devices affected by the recall have been implanted in patients five years or longer.
The Medtronic pacemakers involved in this recall include:
- Kappa Series 600/700/900
- Sigma Series 100/200/300
Patients with the cited models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 1-800-505-4636 or going to the firm’s Web site. Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.
Medtronic Letter to Doctors
The Class I Medtronic pacemaker recall was preceded by a letter Medtronic Inc. issued to doctors in May 2009, alerting them to problems with some Kappa and Sigma pacemakers. The letter discussed two different wire separation issues affecting some Sigma and Kappa pacemakers.
Medtronic said it had received reports of two patient deaths where it is possible, but unclear whether a wire separation issue may have been a factor. A total of 37,000 devices may have been affected by these two issues.
The first issue involved an estimated 15,200 active Kappa devices and 6,100 active Sigma devices, manufactured primarily between November 2000 and November 2002. It was this issue that prompted the 2009 Class I Kappa and Sigma pacemaker recall.
Medtronic said it had observed 285 Kappa devices and 131 Sigma devices with this failure mechanism. Its modeling predicted failure rates of 1.1% for Kappa devices and 4.8% for Sigma over the remaining lifetime of these pacemakers due to this issue.
According to the letter, there is no provocative testing that can predict which specific devices may fail, and no device programming can mitigate this issue if it occurs.
Medtronic updated performance and patient management recommendations of a different subset of Sigma devices
In the same letter, Medtronic updated performance and patient management recommendations of a different subset of Sigma devices with the same possible clinical presentation, previously reported in a November 2005 advisory.
The 2005 advisory was related to wire separations caused by a particular cleaning solvent used in manufacturing and is not related to Kappa/Sigma wiring issue responsible for the 2009 Class I recall. There are currently an estimated 15,600 active implants from this 2005 Sigma device subset, Medtronic said.
Medtronic said that for most patients, device failure from either of these problems could result in slow heart rhythms that would cause lightheadedness or fainting, but not life-threatening complications. These patients should seek medical attention if they experience these symptoms.
In a small number of patients who do need pacemakers to provide life-saving therapy at all times, however, such an event could prove fatal. Medtronic’s letter said that in these cases, doctors may want to consider replacing the pacemaker.
Need Legal Help Regarding Medtronic Pacemaker Sigma Kappa?
The injuries caused by a defective Medtronic pacemaker are painful and traumatic. In many cases, patients implanted with one of these pacemakers will need to undergo additional surgery to have their device replaced. Sadly, in some instances, injuries from a recalled Kappa or Sigma pacemaker may prove fatal.
Our Medtronic pacemaker recall lawyers will do everything legally possible to make sure Medtronic Inc. is held accountable for the suffering caused by its defective Kappa and Sigma pacemakers. If you would like to discuss filing a Medtronic pacemaker lawsuit, please fill out our online form or call 1-800 YOURLAWYER (1-800-968-7529) right away.