All Articles Tagged With: "Defibrillator Lead"
Articles
Medtronic Sprint Fidelis Lead Failure Rates Reportedly As High As 9.2%
According to new research, the failure rate for recalled Medtronic Sprint Fidelis leads, which are small wires used to connect a defibrillator to the heart, could be twice as high as the manufacturer has claimed.
Medtronic Sprint Fidelis Lead Failures Could Hit 30% in Four Years
A new analysis by UBS Investment Research warns that the failure rate for Medtronic Sprint Fidelis defibrillator leads could reach as high as 30% over four years.
Problems with FDA Medical Device Approval Process Identified in New Studies
Two new studies have been published that are highly critical of the way the FDA approves medical devices for human use, saying that the agency requires too few clinical trials, and that often the data in those trials is suspect.
Medtronic Sprint Fidelis Lawsuits in Minnesota State Court Dismissed
A Minnesota judge has dismissed all state court lawsuits against Medtronic over its recalled Sprint Fidelis defibrillator leads. The decision follows a similar dismissal of the federal Sprint Fidelis litigation in January, based on the argument that the medical device manufacturer is immune from liability for injuries caused by their defective defibrillator leads since the [...]
Senate Hearing Held on Restoring Rights to Sue Medical Device Makers
A panel of U.S. Senators heard testimony on Tuesday from patients and medical experts about the potential dangers of defective medical devices and the impact of a recent Supreme Court ruling that insulates manufacturers from product liability lawsuits for injuries caused by certain defective products that were approved by the FDA.
GAO: FDA Oversight of Medical Devices Inadequate
A Government Accountability Office (GAO) review of FDA’s oversight of medical devices has found a number of deficiencies that could expose the public to potentially dangerous and defective medical devices. The report was submitted as testimony today at a congressional hearing regarding legislation that would restore patients’ ability to file product liability lawsuits against [...]
Medtronic Pacemaker Recall: Kappa 600/700/900 and Sigma 100/200/300
The FDA has notified patients and cardiologists of a Medtronic pacemaker recall for approximately 21,000 Kappa and Sigma pacemakers due to a wiring defect that could cause a severe heart injury or death.
Medtronic Pacemaker Defects Reported Among Kappa and Sigma Devices
Approximately 37,000 Medtronic Kappa and Sigma pacemakers could contain a wiring defect, according to an advisory letter Medtronic sent to doctors this month. The defect could cause the pacemaker to fail and potentially result in serious injury or death.
Medtronic Updates Doctors on Reports of Sprint Fidelis Lead Deaths
According to a letter sent to doctors on Friday by Medtronic, Inc., at least 107 deaths have been reportedly linked to their recalled Sprint Fidelis defibrillator leads. However, Medtronic only acknowledges that the defective leads were a “possible or likely contributing factor” in 13 of the cases.
Medtronic Lawsuit Judge will not Remove Himself From Case
U.S. District Judge Richard H. Kyle, who dismissed all federal Medtronic lawsuits filed over the recalled Sprint Fidelis defibrillator lead, has indicated he will not remove himself from the case, despite the possible appearance of bias caused by his son’s law firm representing Medtronic in a number of unrelated matters.
