Navigation Links
Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA
Date:2/25/2010

from the U.S. Food and Drug Administration (FDA) regarding catastrophic failures in some of its lifesaving devices. The charges were filed following a four-year investigation into Guidant's handling of short-circuiting failures of three models of implantable cardioverter defibrillators (ICDs): the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Guidant issued safety advisories regarding the failures in June 2005.

ICDs are lifesaving devices used to detect and treat abnormal heart rhythms that can result in sudden cardiac death, one of the leading causes of mortality in the United States. The devices, once surgically implanted, constantly monitor the electrical activity in a patient's heart for deadly electrical rhythms and deliver an electrical shock to the heart in an effort to return the heartbeat to normal. If they fail to operate properly when needed, a person can die within minutes.

The information alleges that beginning in 2002, Guidant became aware that one of its ICDs, the Ventak Prizm 2 DR, was prone to electrical arcing, rendering the device inoperative and unable to deliver life-saving therapy to the patient in whom it was implanted. Guidant changed the design of the Prizm 2 in November 2002 to correct the problem. The information charges that in August 2003, Guidant falsely told the FDA that the design changes did not affect the device's safety or effectiveness. In fact, the device chang
'/>"/>

SOURCE U.S. Department of Justice
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. TriReme Medical, Inc. Receives FDA 510K Clearance for Glider(TM) PTA Balloon Catheter
2. Chinas leading electronic systems design event to highlight next-generation medical, automotive and green power technologies
3. Sanmina-SCI Tatabanya, Hungary Facility Achieves ISO 13485 Certification for Medical Devices
4. PointCare Donates Diagnostic Tests to Haitian Clinics to Ensure Resumption of Critical HIV/AIDS Patient Care and Bolster Emergency Medical Treatment for Earthquake Victims
5. Solta Medical to Participate in 2nd Annual Lazard Capital Markets Medical Technology Conference
6. Biomedical Advanced Research and Development Authority (BARDA) Project for Radiation Exposure Research Awarded to SRI International
7. Americans Living Longer, Healthier Lives Due to Medical Innovation and New Therapies
8. Varian Medical Systems Showcases Advanced Radiotherapy and Brachytherapy Products at ACRO 2010, February 25-27, Florida, Booth No. 34-35
9. Elsevier is Meeting Todays Medical Students Needs With Online, Mobile and Print Tools
10. Many Americans Enjoying Longer, Healthier Lives Due to Medical Innovation and New Therapies
11. SPO Medical Granted Innovative Baby Monitoring Patent
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... Pa. , Jan. 23, 2015  MedScope ( www.medscope.org ... been nominated for a 2015 Connected World ... Emergency Response System (mPERS), that can be used anywhere, ... technology partner.  In nominating MedScope, ...
(Date:1/23/2015)... /PRNewswire/-- Harwood Feffer LLP ( www.hfesq.com ) is investigating potential ... ("Advaxis" or the "Company") (NASDAQ: ADXS ), ... to shareholders. On January 21, 2015, an ... Advaxis had misrepresented the clinical data for its ADXS-HPV ...
(Date:1/23/2015)... Idaho , Jan. 23, 2015  Now available for ... No. 7,849,611) support that prevents ankle sprains by cushioning ... brace, it fits securely around the outside of any ... mobility & comfort while still offering protection against sprains. ...
Breaking Medicine Technology:MedScope Nominated by RacoWireless for Prestigious 2015 Connected World Magazine Connected World Award 2Harwood Feffer LLP Announces Investigation of Advaxis, Inc. 2The Armor1 Ankle Roll Guard is the New Breakthrough Solution for Ankle Sprain Prevention! 2
(Date:1/22/2015)... WASHINGTON, DC (PRWEB) January 22, 2015 ... conditions in vulnerable communities and cause financial distress to ... report by analysts at Howard University’s Center on Race ... of dollars in economic activity, payday loans at the ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 As interest in ... health care gains momentum worldwide, Rev. Eric J. Hall ... Chaplaincy Network (HCCN), will be the keynote speaker on ... in Israel’s public health system. , The conference, “Hope and ...
(Date:1/22/2015)... a new blog post presenting a list of vehicles that cannot ... Some types of vehicles cannot be covered under an ordinary auto ... see if their vehicle qualifies for auto insurance coverage. , ... that cannot be covered by a plan. Clients have little options ...
(Date:1/22/2015)... Step into a macabre world where plants ... Virginia. Wicked Plants, the Museum’s latest featured exhibition, opens ... carnivorous and diabolical plants inside of a dilapidated, Victorian ... biochemical, physical and neurological processes between botanicals and the ...
(Date:12/26/2014)... December 26, 2014 The US represents the ... report. In 2013, GlobalData’s forecast estimates that sales of branded ... market due to the high incidence of the disease, high ... 5EU, Japan, and China. Increased sales of CRC therapies over ...
Breaking Medicine News(10 mins):Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 3Health News:Some Vehicles Cannot Be Covered By An Auto Insurance Policy! 2Health News:Wicked Plants are taking over the Science Museum of Virginia 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 3Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 4
... Located and Successfully Treated, ASHEVILLE, N.C., Aug. 30 ... this afternoon and has returned to his,mountain home in ... vehicle and made the 20-minute drive home without incident. ... Hospitals in Asheville, NC,early on Saturday, August 18 for ...
... 30 Omnicell, Inc.,(Nasdaq: OMCL ) a leading ... operational efficiency in healthcare,facilities, today announced that Randall A. ... & CFO will present at the Thomas Weisel,Partners Healthcare ... Wednesday, September 5, 2007 at 11:30 a.m. Eastern Time. ...
... today announced that the Department is making available ... areas to help,strengthen their capacity to respond to ... will provide our nation,s health care community,with a ... equipment,for an effective pandemic response," Secretary Leavitt said. ...
... to October 15, 2007, RICHMOND, Va., Aug. 30 ... through organ and tissue donation in,2006, strongly held myths ... Hispanics from becoming organ and tissue donors. In,recognition of ... and encourage the Hispanic community, long celebrated for its,zest ...
... Va., Aug. 30 Ronald Honberg,director of policy and ... issued the following statement on today,s Virginia Tech,Panel Report: ... It exposes problems,that exist not just in Virginia but ... system received a ,D, grade in,a national survey. The ...
... 6-7, Mandarin Oriental, Washington, D.C., ARLINGTON, ... industry,CEOs, along with top Wall Street analysts ... other government officials, will headline the,Generic Pharmaceutical ... 2007. The conference, "Generics: Prescription for Affordable,Health ...
Cached Medicine News:Health News:Billy Graham Home After Hospitalization: 2Health News:Omnicell to Present at Thomas Weisel Healthcare Conference 2007 2Health News:HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness 2Health News:Donate Life America Dispels Myths About Organ & Tissue Donation Among Hispanics During National Hispanic Heritage Month 2Health News:Virginia Tech Report Has National Importance 2Health News:GPhA's 2007 Annual Policy Conference Features Top Generic Industry CEOs; FDA, Government Officials; Wall Street Analysts 2
... A particular challenge in transseptal left heart ... must be exchanged for a sheath with ... wall position. Traditionally, such an exchange has ... heparinized patient. Biosense Webster has overcome this ...
... of guiding introducers includes Swartz™ Series, ... piece steerable, all designed for the ... varying curves and longer sheath lengths ... Jude Medical guiding introducers are designed ...
Novus 30001 A fully-integrated and powerful 532 nm Operating Room Photocoagulator with reliable DPSS technology and simplified operation using a touch screen interface and remote control....
... 1064 nm Nd:YAG Base Platform ... ophthalmologists treating the anterior segment ... the elimination of secondary cataracts ... Selecta platform offers multiple upgrade ...
Medicine Products: