All Articles Tagged With: "Defibrillator"

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Defective Defibrillator Implants Lead to Federal Charges Against Guidant

Federal law enforcement officials have leveled criminal charges against Guidant LLC, a medical device manufacturer that Justice Department officials say knowingly sold defective defibrillator implants to consumers and then tried to cover up attempts to correct the defect.

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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.

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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.

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External Biphasic Defibrillator Problems Being Reviewed by FDA

The FDA has launched an investigation into potential problems with external biphasic defibrillators after receiving a number of reports that some appear to be too low powered.

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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 [...]

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Study: Implanted Heart Defibrillators Ineffective in Women

The results of a new study suggest that women who receive surgically implanted heart devices, known implantable cardioverter defibrillators (ICDs), may not see any significant health benefit, as opposed to men who tend to live longer lives while coping with heart failure if they receive the devices.

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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.

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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.

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Automatic External Defibrillator Recall: Welch Allyn AED 10 and MRL JumpStart AED

Over 14,000 automatic external defibrillators (AED) have been reca

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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.