Category Archives: St. Jude Defibrillators

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Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...

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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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Exploding Tanks Kill Jeep Drivers 18 months after Recall

Exploding Gas Tanks Continue to Kill Jeep Drivers 18 months after Recall

Chrysler recalled Jeeps with exploding gas tanks more than 18 months ago, but 1 million+ of these vehicles have not been fixed as the death toll continues to rise.

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Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker’s recent recall of two metal hip implant components, the Rejuvenate Modular and ABG II modular-neck hip stems, may have dealt a serious blow to one of the key arguments medical device manufacturers have made to defend their metal-on-metal hip replacements. Facing thousands of lawsuits, the makers of ...

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Cancer Groups Issue Statement for Regulation of E-cigarettes

Cancer Groups Issue Statement Calling for Research and Regulation of E-cigarettes

The American Society of Clinical Oncology & the American Association for Cancer Research are calling on the government to regulate e-cigarettes.

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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

The U.S. Food & Drug Administration (FDA) is reviewing a new study that reported an increased risk of sudden, heart-related deaths among people using the antibiotic Zithromax (azithromycin), known popularly as Z-Pak. In a statement issued late yesterday, the FDA said patients being treated with Zithromax should not stop taking ...

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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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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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Faulty St. Jude Riata Defibrillators may have Fatal Consequences

Patients who still have recalled St. Jude Defibrillators leads in their chests have many reasons to be vigilant. Premature insulation failure in the recalled device has been tentatively linked to polymicrobial endocarditis, a serious, often deadly condition that leads to … Continue reading

Posted in Defective Medical Devices, Health Concerns, Product Recalls, Recalled Medical Devices, St. Jude Defibrillators |

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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St. Jude ICD Recall Is Deemed a Class I by Federal Regulators

St. Jude ICD Recall Is Deemed a Class I

St. Jude recently reported two patient deaths tied to early depletion of lithium batteries in St. Jude Medical Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D). The U.S. Food and Drug Administration (FDA) and St. Jude issued an … Continue reading

Posted in Defective Medical Devices, Product Recalls, Recalled Medical Devices, St. Jude Defibrillators | Tagged , , , , |

Premature Battery Depletion of Defibrillator Caused Two Deaths

Premature Battery Depletion of Defibrillator Caused 2 Deaths

On October 11, 2016, the U.S. Food and Drug Administration (FDA) issued a safety warning for premature battery depletion of the St. Jude Medical Implanted Defibrillator. The St. Jude products in question were manufactured before May 2015 and are ICD and CRT-D … Continue reading

Posted in Defective Medical Devices, Health Concerns, St. Jude Defibrillators | Tagged , , , , |

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 Coils that May not Deliver Needed Electric Shocks

Proton-pump-inhibitors

St. Jude Medical has announced the recall of the Optisure Dual Coil Defibrillation Leads because a manufacturing error may have damaged the insulation layer of one of the shock coils. This could prevent the defibrillator from delivering appropriate electrical therapy … Continue reading

Posted in Defective Medical Devices, Health Concerns, St. Jude Defibrillators |

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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Boston Scientific Subpoenaed Over Implanted Cardiac Defibrillators

Boston Scientific Corp. received a subpoena this week from the Department of Health and Human Services (HHS), seeking information about the performance of some of its implanted cardiac defibrillators. The May 5 subpoena came from HHS’s Office of the Inspector … Continue reading

Posted in Defective Medical Devices, Medtronic Defibrillators, St. Jude Defibrillators |

First Bellwether Trial Has Been Scheduled Involving Allegations of St. Jude Riata Injury, Death

The first St. Jude Riata bellwether trial is scheduled for February 3, 2015, according to court documents. The patients chosen for the case allege that the Riata defibrillator leads are defective. In one case, a patient died and the others … Continue reading

Posted in Defective Medical Devices, St. Jude Defibrillators |

Motion to Dismiss Riata Defibrillator Lead Cases Denied

motion-to-dismiss-riata-case-dismissed

A motion to dismiss five cases alleging that manufacturing defects caused St. Jude Medical’s Riata defibrillator leads to fail was denied last month by Federal Judge James V. Selna. Selna ruled that the plaintiffs had met the burden of showing … Continue reading

Posted in Defective Medical Devices, Legal News, St. Jude Defibrillators |

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