 Metal-on-metal replacement hips remain high-risk, but other devices are to be downgraded. Another medic performed CPR for a few minutes, and then used a medical device that delivered cardiac compressions mechanically for 64 minutes, until Mr. Schneider’s heart started beating normally on its own. “I’m not sure people would have been able to sustain manual CPR for so long,” said Mr. Schneider, 57. “I’m a lucky guy.” |
Showing posts with label Minneapolis. Show all posts
Showing posts with label Minneapolis. Show all posts
Friday, November 22, 2013
New Scrutiny for Medical Devices
Saturday, November 16, 2013
Class I Recall: Medtronic's Worldwide Voluntary Field Action on Guidewires
Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to certain guidewires as a Class I recall.
Based on an internal investigation following a limited number of complaints, including one patient injury, Medtronic began notifying hospitals and distributors worldwide the week of Oct. 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach. The notification requested that all potentially affected units be quarantined immediately and returned to the company as soon as possible for credit and replacement.
Medtronic has also taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate.
The FDA defines a Class I recall as a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death.
The guidewires covered by this recall are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices. They include specific lots from the following eight product lines that were manufactured after mid-April 2013:
- Cougar nitinol workhorse guidewire
- Cougar steerable guidewire
- Zinger stainless steel workhorse guidewire
- Zinger steerable guidewire
- Thunder extra-support guidewire
- Thunder steerable guidewire
- ProVia crossing guidewire
- Attain Hybrid guide wire
Additional information about the recall, including the lot numbers of affected product, is accessible through the Medtronic website – specifically, http://www.medtronic.com/for-healthcare-professionals/index.htm.
Observations and consequences of the coating issue related to these guidewires should be reported to Medtronic in the United States by calling +1-877-526-7890 on weekdays from 8am to 5pm U.S. Central Time.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA:
- Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form
available to fax or mail), or - Call FDA at +1-800-FDA-1088
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.
Wednesday, October 30, 2013
Target Bans the Box
 Earlier this year Minnesota extended its existing law to cover private employers. Now, the Minneapolis-based Target Corporation, one of the nation’s largest employers, has announced that it will remove questions about criminal history from its job applications throughout the country. The announcement represents an important victory for the grassroots community group TakeAction Minnesota, which had been pressuring the company to change.This comes on the heels of a similar development earlier this month in California, where Gov. Jerry Brown signed a ban-the-box bill that applies to government employers. The federal Equal Employment Opportunity Commission gave this movement a lift last year, when it expanded and updated a ruling that barred employers from... |
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