Did you know that pacemakers and leads can sometimes be recalled, just like a defective car? That’s right, and it happens more often than you would think. But before you panic that you might have a device on recall from the manufacturer, let’s take the subject slowly. It may not be as bad as you think.

The Food & Drug Administration (FDA–a government agency based in Washington) regulates the medical device industry, including pacemaker and defibrillator manufacturers. When problems occur in these products, the FDA works with the manufacturer to figure out what to do. Any time that a device experiences a problem, doctors can report it to the FDA and it is shared with the manufacturer. When these reports come in, it allows the FDA and the manufacturer to figure out a strategy.

Sometimes the problems are considered “random failures.” The word failure does not mean the device conks out, necessarily, it means it fails to perform according to specification. And like any mechanical device, pacemakers can sometimes just have a problem. If the problem is very very rare, it may be attributed to a random failure. Your doctor may be able to fix it or he or she may enlist the help of the manufacturer to get it fixed.

But sometimes the same problem occurs repeatedly. The FDA keeps getting reports of the same sort of problem in a certain category of devices, say, all pacemakers of a certain brand manufactured around the same time. The FDA then sits down with the manufacturer and they try to figure out what is going on. In many cases, a voluntary recall is issued. This is a curiously named thing, because although the manufacturer states the recall is “voluntary,” it is usually required by the FDA.

When a recall happens, the manufacturer uses its database to see who has these devices (they keep thorough patient records) and the physicians who implanted them. A notice is set out in the form of what the industry calls a “Dear Doctor” letter. This letter describes the problem, the devices affected, and recommends some actions.

You may get a notice in the mail or you may get a call from your physician if you have a device that is the subject of a recall. You will most likely be asked to come in for a visit so that the problem can be explained to you. The doctor will probably have one or more recommendations as to what to do.

Here are 10 important things to know about pacemaker or lead recalls:

  1. Most recalls cover just a subset of all devices. No company recalls all of their products. A recall is typically for a particular model and often for a particular model manufactured during a certain time. Your device can be identified through its serial numbers. So even if Medtronic has a recall, it does not mean the recall affects your pacemaker. And even if does apply to your particular model of pacemaker, it may not apply to the subset of devices you have. So if you hear of a recall–do not worry until you or your doctor check the serial number of the device.
  2. Every recall is different. There have been some relatively “minor” ones and some less minor ones. If you have a recalled device, be open minded and listen to your doctor or nurse explain the situation. Some recalls may just involve having a “software patch” put into the device which involves an office visit and a session at the programmer. Other recalls may require you to see the doctor more often but otherwise take no special steps.
  3. In some recalls, a subset of devices are identified that have the “potential” to have a problem. In such cases, you may be told that you have a certain device and 10% of those devices encounter a problem. This means that even though your device is technically “on recall” you may be in the 90% of people who do not have a device with a problem. In many cases, not all “recalled devices” are going to experience a problem.
  4. The doctor or nurse will recommend some options for you. Sometimes the options are very simple (programming session, accelerated follow-up visits) and sometimes they are more drastic (remove and replace device). You need first of all to ask: what is the worst case scenario? That will help you understand the maximum adverse impact that could happen to you. In some cases, a device is recalled because it may drain the battery faster than normal or it may not allow certain programmable functions. In other cases, you may find out that your device might stop working properly and leave you unprotected. Know what is the worst that can happen.
  5. Next, find out what solutions are out there. The FDA and the manufacturer work together to come up with what can be done to alleviate the problem. In some cases, one solution is so easy and works so well that it is a no-brainer. In other cases, you may be presented with some choices. If you need to have a device removed and a new one implanted, know that there are risks associated with that. Find out the risks associated with each of your available options.
  6. Your physician’s office will talk to you about the financial impact of the recall. In most cases, you will find insurance will cover the problem. If there are special provisions for the recall, talk to your doctor about them upfront.
  7. Most manufacturers do not put a lot of information on their website about recalled products. The reason is not that they want to hide valuable information; the reason is that clinical care for a pacemaker or defibrillator patient is highly individualized. I have an uncle who has a defibrillator lead that is under recall. He was offered a choice: get it removed and replaced or watch it closely. Since he is 90 years old, he opted for the wait-and-watch method. Another younger, fitter person might have chosen to have the lead replaced. Manufacturers usually spell out their recommendations to doctors and expect doctors to help interpret them individually, patient by patient.
  8. If you search online about recalled products, you may find crazy, scary information. Get your information from your doctor.
  9. If you are not sure you have a product under recall, contact your physician and ask. This is a better method than trying to find out recalls from the FDA website. It’s possible to access the FDA site (they’re fda.gov) but it can get confusing to try to identify your precise product.
  10. If you are not happy with your doctor’s recommendations about the recall or if you feel like you’re not getting the whole story, you should do what you would do in any other medical situation like that. Get a second opinion.

 

PDF24    Send article as PDF   
 

Leave a Reply