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:7/23/2014)... Top Staten Island Pediatrician Dr. Michael Gabriel ... discusses tips for parents about pool safety for children. ... to US News article, "Drowning is the leading ... 1 to 4, and can occur in as little as ... article says that watching a child in the water every ...
(Date:7/23/2014)... , July 23, 2014  Mezzion Pharma Co. ... to evaluate the use of udenafil to treat adolescents ... ventricle heart defects. The clinical program will follow protocols ... the Pediatric Heart Network (PHN), a multi-center clinical research ... Institute (NHLBI) of the National Institutes of Health (NIH). ...
(Date:7/23/2014)... July 23, 2014  Nearly 8,000 attendees will converge ... Health,s annual Retail Business Conference (RBC), taking place July ... This year,s event encourages pharmacists to "Lead Change" in ... and for their future. "RBC ... network with their peers and learn new ways they ...
Breaking Medicine Technology:Premier Staten Island Pediatrician Dr. Michael Gabriel Comments On Article Discussing Pool Safety Tips for Parents 2Mezzion Pharma Initiates Clinical Development Program To Evaluate Udenafil In Adolescents With Single Ventricle Heart Defects 2Cardinal Health Encourages Independent Pharmacists to Lead Change at 24th Annual Retail Business Conference 2Cardinal Health Encourages Independent Pharmacists to Lead Change at 24th Annual Retail Business Conference 3Cardinal Health Encourages Independent Pharmacists to Lead Change at 24th Annual Retail Business Conference 4Cardinal Health Encourages Independent Pharmacists to Lead Change at 24th Annual Retail Business Conference 5Cardinal Health Encourages Independent Pharmacists to Lead Change at 24th Annual Retail Business Conference 6
... , NASHVILLE, Tenn. , ... provider of medical cost management services, today commended two new ... scans and other diagnostic imaging tests. , "When used ... said Gregg Allen, M.D., chief medical officer of MedSolutions. "However, ...
... , FORT WORTH, ... Board: WNDM) a rapidly growing provider of specialty medical products, ... toward productization of its patented orthopedic bone void fillers. ... 2010, to the bio-products market, estimated to be a multi-billion ...
Cached Medicine Technology:MedSolutions Applauds Renewed Focus on the Dangers of Radiation Exposure 2MedSolutions Applauds Renewed Focus on the Dangers of Radiation Exposure 3Wound Management Technologies, Inc. Targets Multi-Billion Dollar Biomaterials Market; Releases Update on Resorbable Orthopedics 2Wound Management Technologies, Inc. Targets Multi-Billion Dollar Biomaterials Market; Releases Update on Resorbable Orthopedics 3
(Date:7/24/2014)... TORONTO, ON (PRWEB) July 24, 2014 ... a new survey conducted in partnership with AIIM, ... industries. The most surprising insight of the survey ... to archive outbound customer correspondence for customer service, ... needs, only 44% of organizations save exact facsimiles ...
(Date:7/24/2014)... NJ (PRWEB) July 24, 2014 Losing a ... – overwhelming sadness as well as shock, fear, guilt, anger, ... spouse's death agonizing and confusing. It may be small comfort ... temporary but it is in fact the case that grieving ... says clinical psychologist Dr. Hayley Hirschmann of ...
(Date:7/24/2014)... 2014 Professional Healthcare at Home, an affiliate ... Schulkin, a nurse with the company’s Pleasant Hill, CA, home ... for the 2014 Home Care & Hospice Nurse of the ... & Hospice (NAHC). , Annually, NAHC promotes a nationwide ... to help choose a top home care and hospice nurse ...
(Date:7/24/2014)... Boston, MA (PRWEB) July 24, 2014 ... certification as a Woman-Owned Small Business (WOSB) by the ... is an SBA -approved third party certifier. ... management consultancy that collaborates with clients to drive growth ... assists with both developing insights and activating options through ...
(Date:7/24/2014)... AZ (PRWEB) July 24, 2014 Colleen’s ... has donated $10,000 to Johns Hopkins Medicine to fund ... Billy Cundiff. , According to Cundiff, this is the ... supported ovarian cancer research at Johns Hopkins Medicine. , ... is to work with promising young investigators at some ...
Breaking Medicine News(10 mins):Health News:AIIM Research Shows 56% of Organizations Not Utilizing Digital Archiving Technology 2Health News:AIIM Research Shows 56% of Organizations Not Utilizing Digital Archiving Technology 3Health News:AIIM Research Shows 56% of Organizations Not Utilizing Digital Archiving Technology 4Health News:Coping with the Loss of a Spouse: Is it Grief or Is It Depression? Dr. Hayley Hirschmann with Morris Psychological Group Provides Tips for Grieving 2Health News:Coping with the Loss of a Spouse: Is it Grief or Is It Depression? Dr. Hayley Hirschmann with Morris Psychological Group Provides Tips for Grieving 3Health News:Coping with the Loss of a Spouse: Is it Grief or Is It Depression? Dr. Hayley Hirschmann with Morris Psychological Group Provides Tips for Grieving 4Health News:Professional Healthcare at Home’s Karen Schulkin Named Top 10 Finalist Representing California for 2014 Home Care & Hospice Nurse of the Year 2Health News:Professional Healthcare at Home’s Karen Schulkin Named Top 10 Finalist Representing California for 2014 Home Care & Hospice Nurse of the Year 3Health News:Imbue Partners Certified as Woman-Owned Small Business 2Health News:Colleen’s Dream Foundation Donates $10,000 to Johns Hopkins Medicine for Ovarian Cancer Research 2Health News:Colleen’s Dream Foundation Donates $10,000 to Johns Hopkins Medicine for Ovarian Cancer Research 3
... of cancer drugs can be used effectively while ... is closely monitored and controlled, a clinical panel ... and hypertension experts together to draft new recommendations ... of cancer. First approved in the mid-2000,s, these ...
... those surveyed were ,OK either way, , TUESDAY, May 11 ... childbearing age fall into one of two categories: They are ... children. , But a new national survey suggests there,s a ... women aged 25 to 45 who were polled said they ...
... ... Member Take Championship Title , ... (PRWEB) -- Human Touch ®, the U.S. market leader of innovative massage chairs, Perfect ... PGA Pro Tim Clark for his first PGA TOUR victory in his career at ...
... ... the ‘Real Housewives of New York City’, for emphasizing the importance of choosing a ... reality show. , ... New York (Vocus) May 11, 2010 -- The American Society for Aesthetic Plastic ...
... benefits seen in healthy volunteers, researchers say , TUESDAY, May ... new study shows. , German researchers tested pain responses in ... China more than 2,000 years ago, increased pain thresholds by ... treated leg and untreated (contralateral) leg. , The study also ...
... ... , ... 11, 2010 -- Richard Marbes, Chairman of the Disabled American Veterans (DAV) Charitable Services Trust ... pleased to advise that favorable consideration was given to the funding request for USA Cares ...
Cached Medicine News:Health News:Monitoring and control can limit side effects of promising cancer drugs 2Health News:Monitoring and control can limit side effects of promising cancer drugs 3Health News:Some Women Lack Strong Feelings About Motherhood 2Health News:Human Touch Brand Ambassador and PGA Pro Tim Clark Wins First PGA TOUR Victory at PLAYERS Championship 2Health News:Human Touch Brand Ambassador and PGA Pro Tim Clark Wins First PGA TOUR Victory at PLAYERS Championship 3Health News:The Real Housewives of New York City Know What Questions to Ask When Looking for a Plastic Surgeon 2Health News:The Real Housewives of New York City Know What Questions to Ask When Looking for a Plastic Surgeon 3Health News:The Real Housewives of New York City Know What Questions to Ask When Looking for a Plastic Surgeon 4Health News:Disabled American Veterans Charitable Services Trust Supports OIF/OEF Veterans Battling PTSD 2
... Combines BchiVac V-500 and water-cooled secondary condenser ... is a powerful PTFE membrane vacuum pump ... Applications Ideally suited for use ... Laboratory vacuum source for instruments including ...
... UVS400 is a multi-tasking vacuum source and ... refrigerated vapor trap and a maintenance-free, oil-free ... The easy-to-use, wide-mouth glass condensation flask collects ... for easy disposal. The UVS400 provides an ...
Universal vacuum pump (capacity 34 L/min, 8 mbar vacuum abs.)...
... with Vacuum Controller V-800 Efficiently controls vacuum ... on and off as needed to maintain preset vacuum ... is a powerful PTFE membrane vacuum pump designed to ... suited for use with up to two rotary evaporators ...
Medicine Products: