Buy this domain.

free-best-hosting.com

Medtronic Says Action on SynchroMed and IsoMed Devices Now Class I Recall | 24-7-news.com cialis online

Medtronic Says Action on SynchroMed and IsoMed Devices Now Class I Recall

AddThis Social Bookmark Button

 SynchroMed and IsoMed infusion systems made by Medtronic Inc. are subject to a Class I recall due to an increase in reports of inflammatory masses associated with their use.  Medtronic’s SynchroMed and IsoMed intrathecal drug delivery systems consist of an implantable pump and catheter that deliver small quantities of drug directly into the intrathecal space in the spine. These devices are used to treat chronic, intractable pain and for the management of severe spasticity of cerebral or spinal origin.

A Class I recall indicates a situation in which there is a reasonable probability that use of the product will cause injury or death.On January 16, Medtronic sent a letter to healthcare providers informing them of an increase in the rate of reported inflammatory mass cases in patients who have received intrathecal drug delivery through its SynchroMed and IsoMed implantable infusion systems. This letter was an update to two previous communications on this topic that Medtronic issued in 2001 and 2003. Medtronic announced yesterday that the Food and Drug Administration has deemed the January action a Class I recall.  Despite the FDA’s decision, Medtronic said that it is not changing the recommendations made to physicians in the January 2008 letter and there is no new action required of physicians or patients in regards to the defective SynchroMed and IsoMed infusion systems.

Inflammatory mass is a chronic inflammatory or granulomatous mass at or near the tip of intrathecal catheters and has been reported with the infusion of morphine, baclofen and other physician-prescribed drugs and/or mixtures, including pharmacy-compounded drugs. In the January letter, Medtronic noted an increase in reported cases of inflammatory mass associated with intrathecal drug delivery from 0.1 percent reported to date in 2001 to 0.5 percent reported to date in 2007. The company said that the actual incidence was likely higher than stated due to under-reporting. Medtronic said it has received FDA approval to update the SynchroMed and IsoMed labeling to include this new data. The risk of inflammatory mass formation has been included in the labeling for Medtronic’s SynchroMed and IsoMed implantable drug infusion systems as either a Warning or Precaution, since 2001 and in the prescribing information for Infumorph (preservative-free morphine sulfate for microinfusion pumps) since 2003.

According to Medtronic’s press release, the most frequently reported symptoms of inflammatory mass are decreased therapeutic response, pain, and neurological deficit/dysfunction. Serious reported symptoms include paralysis and other neurological impairments. To date, there have been no reported deaths associated with this issue. Medtronic said the development of inflammatory mass was associated with a wide range of doses and concentrations of opioids. The risk of inflammatory mass occurrence also appeared to increase over time and with higher concentrations of opioids

In the January letter, Medtronic cautioned clinicians to utilize the lowest effective dose and concentration of opioids and to monitor patients closely for early clinical symptoms of inflammatory mass. The letter also recommended diagnostic steps for physicians to consider for patients who have new neurological symptoms aimed at preventing more severe outcomes.

Medtronic said patients with questions should talk to their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday – Friday, 8 a.m. to 5 p.m. CDT.

« »

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