Who will be able to forget 2007 — the Year of the Recall? You name it and – it – has been recalled: pet food, peanut butter, toys, spinach, more pet food, airbags, cars and trucks, more toys, chicken pot pies, bicycles, ground beef, pharmaceutical drugs…the list is endless. On any given day the FDA (Food and Drug Administration), the CPSC (Consumer Product Safety Commission), and NHTSA (National Highway Traffic Safety Administration) have recalled and recalled.
While these recalls are all serious and often deadly, they are not as invasive as a connecting device implanted into the body during defibrillator surgery.
First, a little heart device 101: There are different kinds of defibrillators. The first is portable used at sporting events and on airplanes. Another is used in hospital settings; defibrillators send voltage through two paddles that doctors place on a heart attack victim’s chest area. The invasive defibrillator is implanted into people to regulate their heartbeat by shocking the victim’s heart to restore the normal rhythmic patterns. When a defibrillator is used, it in effect kicks the heart into action again, by resuming pumping blood throughout the body.
Part of the defibrillator is known as the lead. It is a connecting insulating wire threaded through the veins. The lead stretches from the computerized device implanted near the collarbone to the heart, where it is secured into the heart muscle with screws. Electrical signals from the heart travel through the lead to the device, and the device sends its shocks, when needed, back through the same lead. The problem with the Medtronic Sprint Fidelis lead is that it breaks or cracks. When the lead breaks or cracks the device starts to receive electrical noise and thinks the heart is not beating correctly. A pacemaker might send a tiny shock to the heart, but with defibrillators, patients can really feel the power. A defibrillator out of whack can make a person feel like they are being repeatedly struck by lightning.
As of October 4, 2007, there were approximately 268,000 Medtronic defibrillator Sprint Fidelis leads implanted worldwide. There have been five patient deaths. So far Medtronic has confirmed 665 chronic fractures in returned leads on model numbers 6930, 6931, 6948 and 6949.
There is a recall on all unsold Sprint Fidelis leads but what options are available for the 268,000 people who have these implanted heart leads?
Even though Medtronic considers itself the world leader in medical technology by providing lifelong solutions for people with chronic disease – Sprint Fidelis is not its first recall heart implantable devices. In 2005, Medtronic identified nine of 87,000 implanted devices (0.01 percent) with a battery design that exhibited this shorting mechanism. Based on highly accelerated company testing, Medtronic estimates that this rate may increase up to between 0.2 percent and 1.5 percent over the second half of device life.
Medtronic recommends that doctors more closely monitor their patients with Sprint Fidelis leads. Medtronic does not recommend that the Sprint Fidelis leads be removed because the surgery can be difficult or fatal.
In the meantime, what do the 268,000 people already implanted with Sprint Fidelis leads do?