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:6/30/2015)... -- Pulse Light Clinic in London,s ... as part of their ongoing research into the condition. They ... their Rosacea. The survey participants were aged between 20 and ... women. The results revealed some rather surprising statistics: ... attempt to visit their GP for Rosacea treatment. ...
(Date:6/30/2015)... , June 30, 2015 First Choice ... to the Astanza Duality and is the only clinic ... offering professional tattoo removal treatments. The practice has recently ... Removal brand to showcase their focus in the ... residents better results, faster ink clearance, and superior service. ...
(Date:6/30/2015)... 2015  Avanir Pharmaceuticals, Inc. today announced top-line ... treatment with NUEDEXTA ® was associated with ... affect (PBA) in patients with traumatic brain injury ... characterized by sudden and uncontrollable outbursts of laughing ... brain injury. PRISM II is a phase IV ...
Breaking Medicine Technology:84% of Rosacea Sufferers Say NHS Treatments Were "Ineffective" New Survey Reveals 284% of Rosacea Sufferers Say NHS Treatments Were "Ineffective" New Survey Reveals 3First Choice Wellness Care Becomes Tallahassee Leader In Tattoo Removal With Astanza Duality 2First Choice Wellness Care Becomes Tallahassee Leader In Tattoo Removal With Astanza Duality 3Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 2Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 3Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 4Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 5Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 6Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 7
... Calif., Jan. 26, 2012  Cardica, Inc. (Nasdaq: CRDC ... its fiscal second quarter ended December 31, 2011, on Monday, ... host a conference call at 4:30 p.m. Eastern Time to ... company,s business. Conference Call Details ...
... LONDON, Jan. 26, 2012  The IP & Science ... with Brazil,s Institute for Applied Economic Research (IPEA). ... and Policies for Innovation, Regulation and Infrastructure (DISET) ... suite of products, supplying them with generic pharmaceutical ...
Cached Medicine Technology:Cardica to Announce Fiscal 2012 Second Quarter Financial Results on Monday, February 6, 2012 2Thomson Reuters Helps Brazil's Institute for Applied Economic Research Identify New Opportunities in the Generic Drug Landscape 2
(Date:6/30/2015)... ... 30, 2015 , ... According to a June 15th report from ... how sensory stimuli can be used to “decrease children’s anxiety and negative responses during ... autism, will compare patient experience in a “typical dental environment” with one that provides ...
(Date:6/30/2015)... ... June 30, 2015 , ... Lakeview Health, a drug ... the size of its medical staff to further enhance its ability to treat ... nurse practitioners and physician assistants -- now totals 17, compared to 7 in ...
(Date:6/30/2015)... (PRWEB) , ... June 30, 2015 , ... ... ) currently pending in a federal multidistrict litigation now underway in the U.S. ... its next monthly Status Conference. According to the Court’s calendar, that conference has ...
(Date:6/30/2015)... ... 30, 2015 , ... Dr. Sammy Masri of Masri Sports Medicine &Wellness, NJ ... the diagnosis and treatment of non-surgical sports and other musculoskeletal injuries for both adults ... athletics and use exercise to stay healthy and active. Dr. Masri seeks to provide ...
(Date:6/30/2015)... Parsippany, NJ (PRWEB) , ... June 30, 2015 ... ... as executive vice president and general manager of HRA Healthcare Research & ... Plainsboro, N.J.-based Michael J. Hennessy Associates, Inc. (MJH) family of businesses. HRA offers ...
Breaking Medicine News(10 mins):Health News:New Study Aims to Determine if Sensory Stimuli can Ease Dental Anxiety in Children, Notes Medical Center Dental Care 2Health News:New Study Aims to Determine if Sensory Stimuli can Ease Dental Anxiety in Children, Notes Medical Center Dental Care 3Health News:Lakeview Health, a Nationally Recognized Drug Rehabilitation Center in Florida, Doubles Size of Medical Staff 2Health News:Progress of Federal Xarelto Lawsuits Pending in Multidistrict Litigation to Be Discussed During July 9th Status Conference 2Health News:Progress of Federal Xarelto Lawsuits Pending in Multidistrict Litigation to Be Discussed During July 9th Status Conference 3Health News:NJ Top Docs Presents Dr. Sammy Masri; Dr. Masri is Now Offering a Wide Range of Services to his Valued Patients 2Health News:NJ Top Docs Presents Dr. Sammy Masri; Dr. Masri is Now Offering a Wide Range of Services to his Valued Patients 3Health News:NJ Top Docs Presents Dr. Sammy Masri; Dr. Masri is Now Offering a Wide Range of Services to his Valued Patients 4Health News:NJ Top Docs Presents Dr. Sammy Masri; Dr. Masri is Now Offering a Wide Range of Services to his Valued Patients 5Health News:HRA Healthcare Research & Analytics Welcomes 'Creative Problem Solver' as New Executive Vice President 2Health News:HRA Healthcare Research & Analytics Welcomes 'Creative Problem Solver' as New Executive Vice President 3
... at risk of suffering broken bones, torn ligaments, arthritis ... pet, there are veterinarians who can treat these ... Roush, an orthopedic surgeon at the Veterinary Medical Teaching ... ,Roush frequently performs orthopedic surgeries on small ...
... The research by a team of Emory University scientists ... altered by genetic mutations recently identified in Parkinson disease development. ... function and could provide a target for drug therapies to ... disorder of the central nervous system resulting from the loss ...
... highest level of health boosting antioxidants which could protect ... to cancer -- shows latest research. ,Blackcurrant ... and northern Europe and northern Asia. Scientists have found ... than other fruits like apples, strawberries, mangoes or bananas. ...
... show that women with diabetes are still in a high ... death rate. All the advances in medical science have reduced ... sadly it does not seem to apply to women ... men with diabetes has dropped dramatically over the last few ...
... Medicine shows that men can help avoid fractures if ... are common among older people and can have devastating consequences, ... that women should take exercise to reduce the thinning ... age is known as osteoporosis. Women are at particular risk ...
... ban on the use of plastic and polythene materials to ... before flooded Guwahati, throwing the city out of gear ... the use of plastic and polythene is one of the ... be enforced very strictly and there would be penalties like ...
Cached Medicine News:Health News:Some Common Human Injuries Also Common in Dogs 2Health News:Some Common Human Injuries Also Common in Dogs 3Health News:Parkinsons Disease Protein Pathway Identified 2Health News:Diabetic Womens Death Rate Shows No Decline 2Health News:Exercise Reduces Fracture in Men 2
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... 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: