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Legal Nurse Consulting Alert – Medtronic Defibrillator Leads – Wired for Life or Death?

People, including my 85-year-old father, who suffer from aberrant heart rhythms received a shock (literally) last year when Medtronic, manufacturer of the Sprint Fidelis leads used to connect electronic defibrillators to their hearts, were malfunctioning at rates higher than those of other leads. The leads were later pulled from the market, but were not pulled from the recipients. Depending on who you believe, anywhere from 87.9%-94.3% of the leads are still functioning in patients. Many of the recalled electronic defibrillators cannot be changed or removed without a risk of harm to the patient.

Earlier this May, the Heart Rhythm Society, a heart-doctor group representing MDs who implant and extract defibrillators and their associated leads, issued policy statements calling for hospitals to better police the experience and training of the surgeons who extract defibrillator leads. They also issued a statement calling for companies that produce the leads to do a better job of tracking their performance once they’re on the market.

A Certified Legal Nurse Consultant participating in a case where there’s suspicion of a malfunctioning cardiac defibrillator, its leads or an injury that occurred while the leads were being removed, should look closely at the experience of the doctor who connected or extracted the leads. While the new guidelines have yet to take effect, the training and experience may be relevant to the injury. Defense Certified Legal Nurse Consultants may be able to raise the level of experience in the defense of the doctor while plaintiff-side CLNC® consultants will raise lack of experience as evidence of negligence.

The medical-device manufacturers never fail to shock me!

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P.S. Comment and share any information you have about Medtronic defribrillators.

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*The opinions and statements made by Vickie Milazzo, the founder of Medical-Legal Consulting Institute, Inc. are based on her experiences and expertise, should not be applied beyond the specific context provided, and do not guaranty or project actual results. Vickie Milazzo is no longer involved in the operations or management of the business, but is involved as an independent education consultant.

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