Defective Implanted Defibrillator Leads

A common procedure for people with irregular or unusual heart rhythms often receive defibrillators implanted into their chest to provide a necessary shock to maintain a healthy heart rhythm whenever necessary. It was a big, and unwelcome, surprise when the manufacturer, Medtronic, announced last year that their Sprint Fidelis leads were malfunctioning at rates that were higher than other leads. These defective leads were pulled from the implant market but cannot be changed or removed without a real risk of harm to the patient. Numbers vary depending on the source, but in the range of 87.9% to 94.3% of the leads are still in place in patients.

In May of 2009, the Heart Rhythm Society, an American cardiac physicians’ 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. This is especially important given the risk to the patient to remove or change these defective leads. HRS also issued a statement calling for companies that produce the leads to do be more accountable in the tracking the performance of their devices once they’re on the market.

A legal nurse consultant can provide information for a case where there may be a suspicion of a malfunctioning cardiac defibrillator, its leads or an injury that occurred while the leads were being removed. One of the questions that must be answered is the experience of the doctor who connected or extracted the leads. While the new guidelines have yet to be determined in Canada, the training and experience of the physician may be relevant to the injury. Legal nurse consultants for the defence may be able to raise the level of experience as an avenue of defence of the doctor. Legal nurse consultants for the plaintiff will question the lack of experience of the physician as evidence of negligence.

The incidence of medical device failure is a serious one. And is definitely the type of case requiring the expertise of a legal nurse consultant.