The Medtronic lead is one of the most common terms used in the medical science. It is wide used in the treatment of heart problems.
Medtronic recently pulled off its famous Sprint Fidelis lead from the market. These Sprint Fidelis lead, similar to other lead for implantable defibrillators (known as ICDs), is nothing but a specially designed wire which goes from the ICD to the heart. The ICDs are implanted under the patient’s skin underneath the collarbone.
The lead’s function is to monitor the ICD’s heart rhythm, as well as to carry a defibrillating shock from ICD to heart, should a dangerous arrhythmia occurs. In case the lead malfunctions, the ICD will simply not be able to treat or even detect such possible event of arrhythmia. Additionally, a faulty lead can also trigger painful and inappropriate shocks from ICD.
Medtronic has decided to call off the Sprint Fidelis lead from the market, used in approximately 235000 patients as the failure rate was raising to higher than expected. It was reported that the Fidelis has 2.3% of failure rate (which means between 2 and 3 failures for each batch of 100 leads) just within 30 months after its implantation. Medtronic and FDA had no choice but to issue this order referred as Medtronic recall action.
The patients who are already implanted with Medtronic lead now face an unusual situation. They first need to discuss with their family doctors while keeping following things in mind:
1. The reported failure rate of Medtronic Lead, while being announced as higher than expected, is no higher than many other similar brands in the market. A number of ICD leads have failure rates approximating to 2 to 3% in a span of three years. Indeed, lead failure is the most common nature of ‘system failure’ for the ICDs.
2. With as high number of 235000 patients, it won’t take long to find out exactly how many Medtronic leads can lead to malfunctioning as these patients routinely check with their respective doctors and if at all the failure rate is found out to be even higher, it would be immediately reported.
3. Replacing a current lead has two main disadvantages. First, the actual surgery of replacement carries a high risk of significant complications (assumed to be on the higher side of percent) and second, there is no guarantee that the new lead will NOT fail as well. Again, as noted previously, this new lead still has chances of failure just as with current Medtronic lead and they do not differ by large margin.
From all the above points, it is evident that the lead failure is a common problem in all of the ICD therapies. From the past experience, it is easy to see that the failure rate of leads in other products is not extraordinarily lower than Medtronic Sprint Fidelis products. For most the patients, this simply means that they should keep the current lead in place, at least for now. However, they should be ever vigilant and constantly keep an eye out on the performance of the Medtronic lead and also track all the available data on it as soon as it becomes available in the market.
