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

es were made to correct this flaw, according to the information.

In early 2004, Guidant allegedly discovered a similar short-circuiting problem with its Renewal 1 and Renewal 2 devices. Following the July 2004 death of a patient associated with a shorted Renewal in Spain, the information charges that Guidant knew that the physician operating instructions for responding to a short-circuit within the device were false and misleading. In an effort to remedy this, Guidant sent a communication by overnight delivery to physicians which the company dubbed a "Product Update." The information alleges that this communication was actually a correction to the device which attempted to mitigate the safety risk posed by the short-circuiting. Guidant was required by law to alert FDA of this action within ten days. The information charges that Guidant failed to make that notification.

Guidant issued safety advisories on the Prizm 2 and Renewal devices in June 2005. FDA classified those advisories as "Class I" recalls, the most serious classification of recall, concluding that there was a reasonable probability that the affected devices could cause serious adverse health consequences or death.

"The government charges that Guidant committed serious crimes by undermi
'/>"/>

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:3/27/2015)... Zimmer Holdings, Inc. (NYSE and SIX: ZMH) is launching a ... Available in both small (6mm) and large (11mm) ... from Zimmer is a modular system that offers surgeons advances ... System allows surgeons to eliminate steps, as well as ... saved time, costs and overall team effort. "The ...
(Date:3/27/2015)... , March 27, 2015 Report ... for leading ophthalmic drug companies  What does ... pharma ophthalmic industry ? Visiongain,s brand new report shows ... and prospects there. Our 242-page report provides ... areas in the industry and the future market prospects. ...
(Date:3/27/2015)... As of February, InControl Medical, LLC ... women. "Shipping thousands of our devices ... the hundreds of letters, emails and phone calls ... positively impacted by our technology," said Herschel ... recently released Apex, an over-the-counter solution for female ...
Breaking Medicine Technology:Zimmer Debuts New Modular External Fixation System 2Zimmer Debuts New Modular External Fixation System 3Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2015-2025 2Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2015-2025 3Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2015-2025 4Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2015-2025 5Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2015-2025 6Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2015-2025 7InControl Medical Surpasses 40,000 Shipments Of Incontinence Devices For Women 2
... And, No-Cost, Noninvasive Tool Detects Risk for Undiagnosed ... Seven Years, ALEXANDRIA, Va., April 28 ... with undiagnosed diabetes,identify whether they likely have the ... costs and complications associated with this now,epidemic illness, ...
... Fla., April 27 Calvin A. Grant, ... his 60-patient,retrospective case control study that was ... (bromfenac 0.09mg ophthalmic solution) in Lucentis(R),(ranibizumab) treatment ... (AMD) in an oral poster presentation at,the ...
Cached Medicine Technology:Drug Combo Could Lower Diabetes Complications and Costs 2Drug Combo Could Lower Diabetes Complications and Costs 3Drug Combo Could Lower Diabetes Complications and Costs 4Drug Combo Could Lower Diabetes Complications and Costs 5Dr. Calvin Grant Presents Results from Xibrom(TM) Combination Therapy with Lucentis(R) at the 2008 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) 2Dr. Calvin Grant Presents Results from Xibrom(TM) Combination Therapy with Lucentis(R) at the 2008 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) 3Dr. Calvin Grant Presents Results from Xibrom(TM) Combination Therapy with Lucentis(R) at the 2008 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) 4
(Date:3/28/2015)... 28, 2015 An article in Fortune ... could prove critical to organizations that deal with PCI ... aspect of data security, is worsening . Using ... report, every major category out of the twelve measured ... “With all the craziness that has gone on in ...
(Date:3/28/2015)... 2015 How best to treat and ... in orthopaedic medicine. While diagnostic hip injections are commonly ... pain etiology, research presented today at the American Orthopaedic ... suggests that pain relief from this diagnostic injection may ... , “Our study looked to assess if the amount ...
(Date:3/28/2015)... Andrew Hawley of Vintage Rock Posters Inc., ... posters. The Who and the Doors played together at the ... According to Hawley, “The Who toured the United States heavily ... campuses. Perhaps the most famous Who poster was a poster ... Doors on August 2, 1968 at the Singer Bowl in ...
(Date:3/28/2015)... Las Vegas, NV (PRWEB) March 28, 2015 ... a groundbreaking new method of sustainable health. After 18 ... walks of life, including professional UFC contenders, Dr. Jon ... system this summer. , Just some of the immediate ... of energy and vitality, increased levels of strength of ...
(Date:3/28/2015)... Paso Robles, CA (PRWEB) March 28, 2015 ... damage restoration specialists , this week released a report ... worsen the symptoms of asthma sufferers, and according to ... healthy children. , According to the Environmental Protection ... can develop asthmatic reactions. Breathing in mold may trigger ...
Breaking Medicine News(10 mins):Health News:Businesses Dealing With PCI Falling Short On Regular Vulnerability Scans and Pen Testing 2Health News:Businesses Dealing With PCI Falling Short On Regular Vulnerability Scans and Pen Testing 3Health News:Businesses Dealing With PCI Falling Short On Regular Vulnerability Scans and Pen Testing 4Health News:Pain Injections for Hip Arthroscopy Patients May Not Predict Surgical Outcomes 2Health News:Avid Collector from Vintage Rock Posters, Inc. Announces His Search For Original 1960's Who Psychedelic Concert Posters. 2Health News:Celebrity Chiropractor Jon Petrick to Release Sustainable Health System this Summer 2Health News:Water Damage Restoration Specialists Servpro of Paso Robles Release Report on Mold and Asthma 2Health News:Water Damage Restoration Specialists Servpro of Paso Robles Release Report on Mold and Asthma 3
... Breast cancer continues to rise in Iraq, and scientists have ... the underlying molecular and environmental causes in an effort to ... the most common type of malignancy recorded in the cancer ... In Iraq, the continuous rise in the incidence rate is ...
... ), the nation,s leading producer of Omega-3 fish oil and specialty fish meal products, today reported net loss of $6.2 million ( $0.33 ... for the year ended December 31, 2008 . , ... , ... ...
... , ... , ... ... Health regulators, have created for Mr. Burnham a golden opportunity to ban ALL tobacco products in the UK for good on the 21st June. , ...
... of cancer, clinicians have a number of treatment options. ... tumor using an arsenal of cancer-killing therapies. Chemotherapy, where ... is a very powerful weapon in this arsenal. It ... testicular cancer and Hodgkin,s Disease, but works poorly in ...
... Bethesda, Maryland The Board of Directors of the ... of guidelines to govern programs accepting the donation of ... cover the minimum requirements that should be met by ... According to AAA Secretary-Treasurer Richard Drake, Director of Anatomy ...
... Fairhill professor of Orthopaedic Surgery and professor of ... and Penn Center for Musculoskeletal Disorders at the ... the 2010 winner of the Ann Doner Vaughan ... Orthopaedic Surgery. Soslowsky presented his award-winning paper, ...
Cached Medicine News:Health News:Breast cancer incidence among Iraqi women profiled 2Health News:Omega Protein Reports 2009 Results 2Health News:Omega Protein Reports 2009 Results 3Health News:Omega Protein Reports 2009 Results 4Health News:Omega Protein Reports 2009 Results 5Health News:Omega Protein Reports 2009 Results 6Health News:Omega Protein Reports 2009 Results 7Health News:Omega Protein Reports 2009 Results 8Health News:The Electronic Cigarette Company Challenges the Rt Hon Andy Burnham MP to Ban All Tobacco Products on 21st June 2010 2Health News:The Electronic Cigarette Company Challenges the Rt Hon Andy Burnham MP to Ban All Tobacco Products on 21st June 2010 3Health News:The Electronic Cigarette Company Challenges the Rt Hon Andy Burnham MP to Ban All Tobacco Products on 21st June 2010 4Health News:The Electronic Cigarette Company Challenges the Rt Hon Andy Burnham MP to Ban All Tobacco Products on 21st June 2010 5Health News:The Electronic Cigarette Company Challenges the Rt Hon Andy Burnham MP to Ban All Tobacco Products on 21st June 2010 6Health News:Exploiting the architecture of cancers may lead to their destruction 2Health News:The American Association of Anatomists approves guidelines for body donation programs 2Health News:Penn researcher, Louis J. Soslowsky, PhD, winner of the AAOS Kappa Delta Ann Doner Vaughan Award 2Health News:Penn researcher, Louis J. Soslowsky, PhD, winner of the AAOS Kappa Delta Ann Doner Vaughan Award 3
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: