Sprint Fidelis Defibrillator Lead Patients Faced with Difficult DilemmaDec 13, 2007 | Parker Waichman LLP 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 suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear.
Lead replacement is also an expensive procedure, and can cost in excess of $12,000. And even though it made the defective Sprint Fidelis Lead that is now causing so many patients so much anxiety, Medtronic is doing little to absorb the costs of lead replacement. When it first announced the Sprint Fidelis Lead recall in October, Medtronic said would cover the cost of a new lead, as well as pay $800 in medical costs for patients whose lead had fractured. But later, the company extended that coverage to patients without fractures, in cases where doctors advise removing the leads because of the patient’s specific medical condition. Even with Medtronic’s contribution, however, patients who have their Sprint Fidelis leads replaced could still be left with a large medical bill. So far insurers are deciding whether to cover the replacement operation on a case-by-case basis, unless the lead has already fractured.
Patients whose doctors don’t recommend the removal of the Sprint Fidelis Lead have little choice to wait and hope it does not fail. Their defibrillators will need to be reprogrammed and monitored, to improve the odds of catching any developing fractures early. But this precaution does not come with a guarantee that all Sprint Fidelis Lead failures will be caught before a patient is injured, and the component could still fracture without warning.
The number of people left to worry that their Sprint Fidelis Lead will one day fracture is staggering. Sprint Fidelis Leads have been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide, and about 235,000 people still have these leads in their chests. It will be a long time – if ever – before all of these Sprint Fidelis Lead patients can feel secure.