Tag Archives: St. Jude Medical

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Government Penalizes 721 Hospitals for High Rates of Infections, Injuries

Medicare is reducing payments to 721 hospitals, one out of every seven hospitals in the nation, for having high rates of “hospital-acquired” conditions (HAC.

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British Health Agency Strengthens Warnings about Valproate

British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy

Statement issued urging healthcare professionals to give women information on birth defects when Depakote and other valproate medicines are used during pregnancy.

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Boston Scientific Transvaginal Mesh

Tennessee Woman Alleges Boston Scientific Transvaginal Mesh Product Caused Painful Injuries

More reports of painful injuries are being linked to transvaginal mesh. This time, a Tennessee woman has filed a lawsuit against Boston Scientific over its Advantage Transvaginal Mid-Urethral Sling System.

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Tentative Ohio Fracking Regulations Criticized as too Lax

Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.

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Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...

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Knee Replacement Patients Should Consider Nickel Allergies before Surgery

Individuals considering undergoing knee replacement surgery should ask their doctors to run a test to determine if they have a nickel allergy. Determining if a patient suffers from a nickel allergy will ensure the right knee implant is chosen for their surgery, and possibly save them from considerable pain and ...

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Fracking Should be Kept 600m From Aquifers, Study Says

New research on the safety of hydraulic fracturing (fracking) suggests new wells should not be dug within 600 meters of a water aquifer because underground fractures can extend about that far from a dug well. According to a report from UK’s The Guardian newspaper, researchers and geologists at Durham University have ...

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FDA Urged to Ban Powdered Caffeine

FDA Urged to Ban Powdered Caffeine

Pennsylvania Senator Robert Casey has written to the Food and Drug Administration (FDA) to urge the agency to ban powdered caffeine, a dietary supplement.

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former NantHealth executives claim that the company made fraudulent claims about the reliability of its system, which links patient information gathered by the devices.

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After Fixing Battery Defect, St. Jude Continued to Sell Older Pacemakers

Early Battery Depletion with St. Jude Medical ICDs & CRT-Ds

St. Jude Medical is facing criticism regarding certain models of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). These heart devices deliver electrical shocks or pacing in patients. Recently, certain models of the Fortify, Unify and Assura … Continue reading

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Investigation of St. Jude Medical Devices Now Includes FDA

Investigation of St. Jude Medical Devices Now Includes FDA

The U.S. Food and Drug Administration (FDA) has now joined the investigation into security claims that devices made by St. Jude Medical can be hacked remotely. These claims are still being defended by St. Jude. Muddy Waters Capital, an investment … Continue reading

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St. Jude Medical Recalls Defibrillator Leads Due to Damaged Insulation

defibrillator-implant

On January 22, 2016, device maker St. Jude Medical announced that a voluntary global field safety action related for the company’s Optisure Dual Coil Defibrillation Leads has now been designated a Class 1 advisory by the Food and Drug Administration … Continue reading

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