Monday, April 09, 2007

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.



Anonymous said...

I have a question for you regarding your comment, "The problem, they think, is possibly due to implanter technique since it has not been seen across all centers across the nation." How could one locate which centers are impacted?

I just had a lead fracture and unfortunately received multiple shocks. My EP MD noted that he has recently seen 3 patients now with lead fractures. I have a had time believing that the fracture is from the implanter technique as the EP MD has been performing this procedure for over 10 years and has only recently had problems with lead fractures. Any ideas or suggestions?

DrWes said...

How could one locate which centers are impacted?

Medtronic might be able to help you identify the sites affected. Although I have no idea how long your lead was installed before the problem arose (more chronic leads are more difficult to remove intact), if the lead can be extracted in its entirely and without significant damage to the lead, a root cause analysis could be performed to determine the issue with your lead. Check with your doctor about this. Sometimes NOT extracting a lead may be the safest approach.

While the full details about the issues with this lead are not known to the public at large (like you and me), the small size of the Sprint Fidelis lead (7Fr) seems to be an issue. The issue may NOT be with the implanting physician but rather an engineering issue - but again, my discussion with Medtronic suggested that they felt, due to the clustering of cases reported, that implant technique may factor significantly. I wish I knew more. Hope that helps a bit.

Anonymous said...

I unfortunately already have two leads. I have to have a lead extraction surgery, I am just not sure If I want a new ICD now. It would be my third ICD in four years as my first ICD was recalled. .. .

My biggest concern for other patient's out there is really to prevent anyone else from receiving as many shocks as I did. Neither the EMTs nor the ER doctor turned off my ICD even when knowning that I was not having any cardiac signs or symptoms. Also (secondary), my lead fracture began 12 days prior to my receiving the shocks and the device did not give me any alert tones.

I am just trying to figure out as much information as I can as I would never want anyone else to have this happen to them. Thank you for any suggestions you have.