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FDA Approval of Devices Raises Questions
The debate over the approval process of medical devices at the FDA continues. The FDA’s approval process for heart devices such as pacemakers and stents is being scrutinized, based upon results of two recent studies. Safety targets often weren’t clearly spelled out in the research submitted by device makers and important patient information was missing, [...]
Medtronic Warned About Problems at Heart Device Plant
The Food and Drug Administration has warned Medtronic Inc. about problems found during a recent inspection of the company’s Minnesota facility where pacemakers and other cardiac devices are made.
Study Finds Major Problems From Surgeries to Replace or Add Pacemaker Wires
A new study finds patients risk serious and potentially fatal complications when they undergo surgery to replace or add wiring to implanted pacemakers or other devices designed to stabilize heart rhythms.
Medtronic Warns About Faulty Batteries in Implanted Heart Devices
Medtronic Inc., a worldwide leader in heart defibrillators, pacemakers, and other implantable heart devices, is warning patients and doctors about problems with the batteries in about 6,300 of the company’s defibrillators.
Wireless Pacemakers Receive FDA Approval
Two wireless-ready pacemakers made by St. Jude Medical Inc. have been approved by the Food and Drug Administration.
Medtronic Recalling Three Million Insulin Infusion Sets; Units May Deliver Wrong Amounts of Insulin
Medtronic Inc., a leading manufacturer of medical devices, is recalling about three million of its insulin infusion sets because the units may deliver incorrect amounts of insulin to patients, possibly causing severe injury or death, according to a report today in The Wall Street Journal.
Dismissal of Medtronic Injury Lawsuits Sends Wrong Message to Injured Patients
A federal judge in Minneapolis has dealt a major blow to the rights of thousands of people across the United States who are killed or injured by defective medical devices. Citing a recent U.S. Supreme Court decision, the judge dismissed more than two dozen personal injury lawsuits which had been filed seeking damages caused by [...]
