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:12/17/2014)... , Dec. 17, 2014 PCCA received ... ( http://bit.ly/1382OkS ) program seal for best ... The program highlights medical practices, materials and goods ... friendly." Children affected by autism often ... be exacerbated by ingredients found in food and ...
(Date:12/15/2014)... 12, 2014 Research and Markets ... the "MEMS Gyroscopes Analog Devices ADIS16136 Precision ... to their offering. ... grade applications made a lot of progress in ... They are now accepted in high-reliability environments, and ...
(Date:12/15/2014)... 12, 2014 Research and Markets ( ... "Inferior Vena Cava (IVC) Filters - Global Trends, Estimates ... http://photos.prnewswire.com/prnh/20130307/600769 Global ... reach US$435 million by 2016. The North ... the global value while Europe ...
Breaking Medicine Technology:Parents Of Children With Autism Spectrum Disorder Have New Options When Administering Medications 2Parents Of Children With Autism Spectrum Disorder Have New Options When Administering Medications 3MEMS Gyroscopes Analog Devices ADIS16136 Precision Angular Rate Sensor Reverse Costing Analysis 2Inferior Vena Cava (IVC) Filters - Global Trends, Estimates and Forecasts, 2012-2018 2Inferior Vena Cava (IVC) Filters - Global Trends, Estimates and Forecasts, 2012-2018 3Inferior Vena Cava (IVC) Filters - Global Trends, Estimates and Forecasts, 2012-2018 4
(Date:12/19/2014)... Slone Partners , a national recruitment firm ... and laboratory testing industries, has promoted Leslie Loveless ... announcement comes after a year of expansion by ... Boston and several new additions to the team. ... experience," said Adam Slone, Chief Executive Officer. “Diagnostics ...
(Date:12/19/2014)... Consilium Staffing, Your Partner in Locum ... Federal Health Professionals annual meeting in Washington, D.C., ... and federal healthcare providers. , In addition, ... Engagement (NVSBE) conference last week in Atlanta, Georgia. ... solution in addressing our nation’s shortage of physicians,” ...
(Date:12/19/2014)... Dec. 18, 2014 (HealthDay News) -- A new study ... moderate to severe hot flashes and night sweats -- ... Hot flashes are common during menopause, affecting about ... also affect women after menopause, since they then face ... "Our findings suggest women who exhibit moderate or severe ...
(Date:12/19/2014)... Randy Dotinga ... News) -- Common painkillers, including ibuprofen, might slightly reduce ... researchers say. Use of ibuprofen (Advil, Motrin) and ... cell skin cancer by 15 percent, the researchers concluded ... is usually caused by sun exposure. ...
(Date:12/19/2014)... HealthDay Reporter THURSDAY, Dec. 18, 2014 (HealthDay ... at least 20 seconds you may be at risk of ... leg may indicate that small strokes or tiny bleeds have ... is high, the investigators reported online Dec. 18 in the ... on one leg, as well as problems walking, should receive ...
Breaking Medicine News(10 mins):Health News:Slone Partners Promotes Leslie Loveless to Chief Operating Officer 2Health News:Consilium Staffing Increasing Awareness of Locum Tenens through Conference Appearances 2Health News:Severe Hot Flashes During Menopause May Raise Hip Fracture Risk Later: Study 2Health News:Common Painkillers May Help Prevent Certain Skin Cancers, Study Finds 2Health News:Common Painkillers May Help Prevent Certain Skin Cancers, Study Finds 3Health News:Can You Balance on One Leg? You May Have Lower Stroke Risk 2
... The preoperative assessment of breast cancer patients for ... which serves to enable the early diagnosis and ... data from a five-year study published this week ... ( http://www3.interscience.wiley.com/cgi-bin/abstract/118821880/ABSTRACT ). , In a study ...
... Medical Systems,(AMEX: LMZ ; TSX:LMZ), a healthcare technology company ... obstetrics is pleased to announce,receiving a score of 88.8 ... the healthcare IT industry. LMS met the criteria to ... and is pleased to have received the,highest performance score ...
... designed to selectively weaken specific muscles may provide an ... attractive alternative treatment for frown lines, ... BFRM ) announced that it has acquired substantially ... Cosmetic Intervention,Inc. (ACI) and associated technology rights for $12 ...
... SpaBrite Teeth,Whitening System(TM) has introduced an FDA ... improves the look of discolored teeth. The company,created ... as,a natural addition to the spa experience. Now ... environment without compromising the effectiveness,of the treatment., ...
... Calif., April 29 The following,release was issued today ... United Healthcare Workers-West (UHW) and its allies,inside SEIU have ... and,retaliation, to reform our International Union., The most ... plans,to sue UHW leaders. UHW,s elected executive board members ...
... It,s "Cover the Uninsured Week," an,annual campaign ... 47 million,Americans who live without health insurance., ... (NYSE: PFE ) at:, http://media.medialink.com/WebNR.aspx?story=35042 , ... text, graphics and,photos for free and unrestricted ...
Cached Medicine News:Health News:Preoperative assessment of cancer patients enables early diagnosis, treatment of lymphedema 2Health News:LMS CALM(R) receives high customer satisfaction scores in the 2008 KLAS Labor and Delivery report 2Health News:LMS CALM(R) receives high customer satisfaction scores in the 2008 KLAS Labor and Delivery report 3Health News:BioForm Medical Acquires Facial Aesthetic Nerve Ablation Technology 2Health News:BioForm Medical Acquires Facial Aesthetic Nerve Ablation Technology 3Health News:BioForm Medical Acquires Facial Aesthetic Nerve Ablation Technology 4Health News:BioForm Medical Acquires Facial Aesthetic Nerve Ablation Technology 5Health News:Beautiful Teeth Not Just for the Dentist's Office Anymore / SpaBrite Teeth Whitening System(TM) Introduces Innovative, New Teeth Whitening Experience To Spas 2Health News:Statement by UHW President Sal Rosselli on SEIU Threat to Sue UHW Leaders 2
Optical Urethrotome 8667 for telescope 4 mm, 0. For slitting urethral strictures under vision...
OES Pro Optical Urethrotome...
... With a 4.9mm insertion tube, ... and increases maneuverability even through strictured ... wide viewing angle of 125 in ... a large viewing area and simplifying ...
New technology in optics, processing and application. Laser-welded mechanics in stainless steel provide high safety in sterilization. Saphire windows distal and proximal, validated even for autoclavi...
Medicine Products: