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Medtronic Inc. has issued a letter to doctors stating that a defective lead wire in its popular heart defibrillator, which was recalled in October 2007, may have contributed to the deaths of 13 individuals in which the heart devices were implanted, according to the Star Tribune. That death toll is up from the medical device company’s original estimate two years ago of five deaths.
Congressional dems seek reversal of Supreme Court DecisionA new study published Monday in the Heart Rhythm medical journal suggests that the more than 200,000 recipients of Medtronic heart defibrillator leads may be at a greater risk than previously thought.
U.S. District Judge Richard Kyle dismissed thousands of lawsuits against Medtronic Inc., manufacturer of the faulty Sprint Fidelis defibrillators that have allegedly injured and killed several people. Attorneys serving the patients, however, may seek to have the judge disqualified from the case because he never disclosed that his son works for the law firm representing Medtronic.
The U.S. Food and Drug Administration (FDA) approved a software update from Medtronic that will help detect fractures in the company’s Sprint Fidelis cardiac defibrillator lead. The software will alert both patients and physicians of a possible fracture in the defibrillator lead. Earlier intervention in the event of such a fracture will help patients avert the serious complications that can arise.
A patient affected by Medtronic’s 2007 recall of defibrillator leads is suing the company, claiming unnecessary shocks led to post-traumatic stress syndrome that required psychiatric treatment.
The 2007 Medtronic Sprint Fidelis Defibrillator Lead Recall could just be the tip of the iceberg when it comes to defective implantable medical devices. That’s because the number of medical devices meant to be implanted in patients’ bodies is rapidly rising. Unfortunately, despite their rising numbers, as the case of the Sprint Fidelis Lead recall illustrates, the Food & Drug Administration (FDA) is doing a poor job of regulating implantable devices, and often ignores reports of device failures until someone dies.
Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, announced last week that it had reached a settlement agreement regarding another of its faulty medical devices. The company has agreed to pay out $114 million to settle product liability lawsuits filed as the result of injuries cased by its malfunctioning Marquis line of implanted cardiac defibrillators. Despite the huge settlement agreement, Medtronic said it does not admit liability in the litigation.
In early December, Jerry Jackson received the shock of his life. Or six. The 63-year-old Mineola resident was sweeping crumbs off the bed where his granddaughter sat when a sudden surge in his chest caused him to twist in agony.
Many patients implanted with defective Medtronic Sprint Fidelis Defibrillator Leads have found themselves in a medical limbo. If they are fortunate enough not to have already experienced a lead fracture, they must decide between two difficult choices, leave the Sprint Fidelis lead alone and hope it won’t fracture; or undergo a difficult and dangerous surgery to have the faulty lead replaced. Both options are bad ones, a fact that has left many Sprint Fidelis Lead patients anxious and confused.
Medtronic Inc., the maker of the faulty Sprint Fidelis Defibrillator Lead Wire, is now facing a lawsuit filed by a group of Canadians who claim the company failed to warn consumers of a defect in the batteries installed in its defibrillators. Last week, Ontario Superior Court Judge Alexandra Hoy certified the class-action lawsuit in a ruling released Dec. 6 in Toronto, allowing the plaintiffs to seek a portion of Medtronic profits for damages.
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