When a Medical Device Advisory is Not an Advisory

I noticed something interesting in the medical device industry this week. It seems companies who make pacemakers and defibrillators are using a “non-advisory” to notify physicians about problems with their devices.

What is a "non-advisory?" Well it’s a “Dear Doctor” letter informing the doctor about a problem they have identified in a small number of their devices. But unlike advisories, these notifications are not published in the company’s websites, but details about them are told to doctors, with some specifics not forthcoming since they might be “works in progress.” In the last two weeks, I have received two such "non-advisories:"

• Medtronic: Seems there is a problem with their premier defibrillator lead, the ultra-small Sprint Fidelis 7Fr defibrillator leads. The problem, they think, is possibly due to implanter technique since it has not been seen across all centers across the nation. It seems these leads are subject to fracture at either the tie-down sleeve or the distal tip of the device if there’s a bend at the end of the device, or if the distal portion of the lead becomes bent during the implant process. The exact distribution of centers with this problem was not reported. (To my knowledge, we have not seen this fracture yet).



• Boston Scientific: Yep, today I was notified about another small capacitor problem in their ICD line, the Vitality and Latitude defibrillator lines that occurs after the battery is connected to these faulty capacitors – a small percentage of them go through a chemical degradation process, I was told. This process can cause a small percentage of them to rapidly deplete the battery of the defibrillator, shortening the time between its Elective Replacement Indicator and its End-of-Life Indicator. Usually, the time between these two indicators is separated by about 3 months, but this might be shortened to as little as one month in devices with these faulty capacitors. They have found this in 19 of 73,000 devices so far and fortunately no injuries have been reported. But it is thought this defect may occur in up to 2% of their implanted devices. Boston Scientific is no longer using that capacitor supplier in their manufacturing process, fortunately.

So, are these product advisories or “non-advisories?” I’m not sure. But it is clear companies are “bringing it to doctors’ attention” when such device issues are identified. But it is VERY clear that these notifications will not be provided to the lay press. This is probably a good thing, since the management of the issues is best left up to physicians savvy in devices, I believe. But there should be a central location of these “non-advisory” ‘Dear Doctor’ letters on the companies' websites that can be found by those managing these devices, since, at their current rate, it looks like doctors will receive about 52 of these notices per year.

-Wes