Category Archives: St. Jude Defibrillators

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Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...

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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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Fracking Releasing Hazardous Chemicals into Local Waterways

Fracking Releasing Hazardous Chemicals into Local Waterways

Study shows two hazardous chemicals—ammonium & iodide—are being released & spilled into Pennsylvania and W.Virginia waterways from fracking operations in Marcellus shale.

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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...

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FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety

An advisory panel for the U.S. Food & Drug Administration (FDA) began a highly-anticipated meeting yesterday to discuss the safety of metal-on-metal hip implants. Among other things, the panel of outside experts is being asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements. ...

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Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

According to a new study, failing metal-on-metal hip implants generate toxic nano-particles that release Cobalt 2+ ions, which not only cause inflammation in surrounding tissue, but have the potential to cause long-term damage to the genetic material of cells. According to a report published by Medicalxpress.com, this “genotoxicity” could ...

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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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Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...

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Warning for Medtronic InterStim Neurostimulation Devices

Australian Health Agency Issues Warning for Battery Problem with Medtronic InterStim Neurostimulation Devices

Warning for Medtronic InterStim Neurostimulation DevicesTGA has issued a safety warning for InterStim and InterStim II neurostimulation devices, because of possible early depletion of the battery.

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Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications

A man in Louisiana has filed suit against Medtronic Inc. over injuries allegedly cause by off-label use of its Infuse Bone Graft product. The plaintiff, who received Infuse during transforaminal spinal lumbar fusion surgery, claims that the bone growth protein caused unwanted bone growth along his spine, worsening the back ...

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Riata Lawsuits Challenge Liability Protection for Device Makers

Lawsuits are being filed against St Jude Medical Inc., the device maker that manufactures the controversial Riata defibrillator leads. The cardiac devices have been associated with numerous reports of deaths and injuries. The Riata was removed from the market in … Continue reading

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St. Jude Medical Strongly Warned by Federal Regulators Over Durata Lead

The U.S. Food & Drug Administration just issued another, stronger warning to St. Jude Medical about its Durata electrical heart lead. The warning letter discussed either imposing a fine or other, serious, actions against the medical provider for not responding … Continue reading

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Report Raises Concerns Over St. Jude Heart Device

A just-released federal inspection report on Sylmar, California’s  St. Jude Medical facility is raising concerns. The report, released by the U.S Food & Drug Administration (FDA), revealed serious flaws in St. Jude’s testing and its oversight of what The New … Continue reading

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St. Jude likely to receive FDA warning letter following inspection of California manufacturing facility

St. Jude Medical Inc. believes it is likely to face a regulatory warning letter on the heels of a recent Food and Drug Administration inspection of a California manufacturing facility that makes some of its troublesome cardiac defibrillator leads. According … Continue reading

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St. Jude Riata Lead Defects Have One Family Living in Fear

The mother of a little girl who has already been through one painful ordeal because of a defective defibrillator lead wire now lives in fear that the St. Jude Riata defibrillator lead her daughter received as a replacement could go … Continue reading

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St. Jude Riata Lead Patients Face Rising Medical Bills

Patients who have been implanted with St. Jude Medical’s now-recalled Riata defibrillator leads will likely face some hefty medical bills.  According to a report from The Wall Street Journal, doctors are increasingly removing St. Jude Riata leads, a procedure that … Continue reading

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New Study of St. Jude Durata Defibrillator Lead Wires Raises Red Flags

A new study conducted by a prominent cardiologist is raising concerns about St. Jude Medical’s line of Durata defibrillator lead wires.  According to Dr. Robert Hauser, a new type of coating  that is used on the Durata lead may not … Continue reading

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Heart Device Patients with St. Jude Riata Leads Need X-Rays to Check Insulation, FDA Warns

Federal health regulators are warning that patients with implantable cardiac defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices that are connected to their hearts via St. Jude Medical’s Riata or Riata ST lead wires need to undergo x-rays or other … Continue reading

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St. Jude Says Analysis Shows Durata Lead Failure Not Related to Riata Flaws

St. Jude Medical has acknowledged that one of its Durata defibrillator lead wires suffered from “externalized abrasion,” but denies that the model suffers from the same type of critical flaw that forced it to pull its Riata lead wires from … Continue reading

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Top Doctor Says St. Jude Durata Lead Failure Report is Credible

A top cardiologist is of the opionion that a Durata lead failure report is, in fact, credible. We recently wrote that the U.S. Food & Drug Administration (FDA) received a report of a St. Jude Durata cardiac defibrillator lead wire … Continue reading

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