cialis online

Medtronic Kappa, Sigma Pacemakers Could Fail Due to Wiring Issues

AddThis Social Bookmark Button

Medtronic Inc. has informed doctors and patients that wiring issues on its  Kappa and Sigma implantable defibrillators could cause the devices to fail. Medtronic’s letter said the issues, which could cause wires that connect the electronic circuit to other pacemaker components to separate,  could affect a total of  37,000  Kappa and Sigma pacemakers.  The company has posted a tool on its website for checking pacemaker serial numbers to determine whether a particular device could potentially have issues.

According to a letter sent to doctors,  one of the wiring issues was 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 a new Kappa/Sigma wire separation issue also discussed in the letter. There are currently an estimated 15,600 active implants from this 2005 Sigma device subset, Medtronic said.

According to a report in The Wall Street Journal, the 2005 advisory told doctors that the issue required “watchful waiting”.   But because the failure rate from this problem is higher than first thought, the company  now recommends that replacement be considered for some patients with Kappa or Sigma pacemakers.  Medtronic  said in its letter that the current risk  of  failure for the Sigma pacemakers affected by this problem is less than 4% over the lifespan of the devices.

A second, and newer separation issue affects an estimated 15,200 active Kappa devices and 6,100 active Sigma devices, manufactured primarily between November 2000 and November 2002.  The Medtronic letter said most of these devices were implanted in patients for five years or longer and may be nearing normal elective replacement time.

Medtronic said it  has observed 285 Kappa devices and 131 Sigma devices with this failure mechanism. Its modeling predicts 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 said that for most patients, device failure from either of  these issues 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.

Medtronic said it has received reports of  two patient deaths where it is possible, but unclear, whether a wire separation issue may have been a factor.

« »

Leave a Reply

You must be logged in to post a comment.

NEWS CATEGORIES

GOVERNMENT NOTICES

ARCHIVES


Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!
defective-hip-replacement.com

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!
CAT-Scans-Radiation-Exposure.com

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.
WaterContaminationFrom Fracking.com

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to PCBs.com

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!
TallisPhoto.com

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO
Poligrip-Lawsuit.com

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!
Nassau-Personal-Injury-Lawyer-Online.com

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!
nursing-home-blog.com

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!
www.nassau-car-accident-lawyer-online.com

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!
www.suffolk-car-accident-lawyer-online.com

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!
www.veterans-benefits-denial.com

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!
www.oil-rig-spills.com

Whistle Blower

Stand up and say what you think is right. See something, say something.
whistlebloweradvisor.com