| Subject: | FDA Announces Class I Recall of Medtronic Kappa Series 600, 700, 900 and Sigma Series 100, 200, 300 Pacemakers |
| Category: | Food and Drug Administration (FDA)
|
| Published: | Thu, 11 Jun 2009 - 04:00 pm |
| The Food and Drug Administration (FDA) has announced a Class I Recall of Medtronic Kappa Series and Sigma Series 100/200/300 pacemakers due to a failure of the devices to pace the heart. 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. These devices may fail due to a separation of wires that connect the... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
|
RESOURCES:
External Links:
|
|
With over 20 years experience in regulatory compliance, MCN Healthcare brings you the most comprehensive regulatory compliance tool available. StayAlert! is the only comprehensive e-mail notification service available that not only notifies you of the changes in major federal regulations, but also provides the policies, procedures, tools and best practices to help you meet the changing regulation. StayAlert! actively monitors TJC (JCAHO), CDC, CMS, DHHS, FDA, OSHA, OIG and many others so you don't have to. The StayAlert! system was designed by healthcare professionals actively working in the healthcare environment, who were faced with attempting to competently provide quality care and services while "doing more with less". StayAlert! provides the answer to efficiently performing a variety of required job components from one centralized virtual location. StayAlert! improves data sharing and communications, thus reducing cost, broadening access and providing a system of documentation and follow-up. |
|
