Patients with Medtronic’s Sprint Fidelis leads are voicing their frustrations over not only whether to have their leads replaced, but also with the company’s $800 offer for replacement – a fraction of the actual cost.

The initial recall

Medtronic Inc., one of the nation’s largest medical device manufacturers, recalled its Sprint Fidelis defibrillator lead on October 15th, 2007 because some of the leads (specifically numbers 6930, 6931, 6948 AND 6949) could fracture causing patients to be unnecessarily shocked or not shocked at all. Defibrillator leads are very thin wires that connect a defibrillator (a device that monitors a patient’s heart rhythm) to the heart. Both the defibrillator device and the lead wires are surgically implanted in a patient’s chest.

Two months later…

Two months after the initial recall, patients with the leads are deciding whether to have those leads replaced. Many have voiced their frustrations on internet blogs saying that they feel like walking time bombs. While the recall affected 235,000 patients worldwide – 172,000 in the US alone – not all of the leads may be subject to fracture. The problem is – nobody knows which leads might fracture. Imagine walking around with an implanted device that monitors your heart rhythm and wondering if today might be the day that it stops working… Patients are reporting that they just don’t feel safe and are considering having the lead replaced for peace of mind.

But who pays?

Since replacing the leads requires risky – and expensive – surgery, patients have also expressed frustration at Medtronic’s offer to only pay $800 towards the replacement. The company has specifically said that it will not pay for procedures to replace functioning leads that patients want taken out to head off possible problems in the future.

The actual cost of replacement has been reported as being upwards of $12,000. Insurance companies are deciding whether to cover the surgery on a case by case basis. However, as anyone who has dealt with an insurance company knows, if it isn’t broken – then they probably won’t pay the costs. This may leave many patients to fend for themselves when it comes to replacement – something most simply cannot afford.

If you or a family member have been injured or died as a result of this device, contact an attorney who can evaluate your case. To contact an attorney whose practice focuses in this area of law, click here.