| Subject: | FDA Issues Medical Device Safety Information for a Subset of Guidant Implantable Pacemakers, Cardiac Resynchronization Therapy Pacemakers and Implantable Cardioverter Defibrillators |
| Category: | Food and Drug Administration (FDA)
|
| Published: | Wed, 28 Jun 2006 - 10:00 am |
| Audience: Cardiac healthcare professionals, risk managers and biomedical engineers
Guidant and FDA have notified healthcare professionals and patients that a subset of implantable pacemakers, cardiac resynchronization therapy pacemakers and implantable cardioverter defibrillators [ICDs] is associated with five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier.
The affected models are:
INSIGNIA 0482, 0484, 0485,... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
|
REFERENCE:
External Links:
|
|
StayAlert! notifies healthcare customers of all federal and regulatory body legislation changes impacting the healthcare industry, including TJC (JCAHO), CDC, CMS, DHHS, FDA, OSHA, OIG and many others. StayAlert! complements this with regulatory implementation action plans. StayAlert! serves as a virtual healthcare department, augmenting traditional employee staffed departments and freeing employees to perform other vital functions. Currently StayAlert! is the leader in the comprehensive compliance information marketplace. Why? Because StayAlert! provides healthcare professionals with more than information. StayAlert! provides a service, in many cases "doing the work" for you, and assisting regulatory compliance officers to effectively and efficiently meet changing standards. |
|
