How safe are ICDs and pacemakers?

Martin Jan Schalij, cardiologist and chairman of the Dutch Society for Cardiology (NVVC): “Every year, five to six thousand people receive an ICD to cardiac arrhythmias to counteract. About ten to twelve thousand heart patients receive a pacemaker to make the heart beat more regularly. The chance of an ICD or pacemaker failure is less than one in a thousand, but if something goes wrong, it can have far-reaching consequences.”

What can go wrong with ICDs and pacemakers?
“ICDs and pacemakers are very safe, but like all electrical appliances they can have technical defects. Leads may wear out, battery may drain faster than expected, software may malfunction. Manufacturers’ data shows that up to 4 percent of new ICDs and pacemakers on the market have something not working quite right. We therefore have to regularly call patients to have their device checked. Fortunately, most of the time these are not life-threatening problems and the device continues to work normally. Then we just need to check more often or install new software.”

But last year things went seriously wrong with a series of ICDs.
“Yes, the manufacturer of two types of ICDs, St. Jude Medical, discovered that the device could short-circuit, causing patients to receive additional shocks: a serious defect that can be life-threatening. All patients with such a device have been summoned and The ICDs of the patients who had something wrong with them have been replaced. This is a complex procedure that entails the necessary risks.”

Should people with an ICD or pacemaker be concerned?
“Treatment with an ICD or pacemaker is still very safe: the risk of death decreases from 30 percent to 1 to 2 percent per year. People with an ICD or pacemaker are regularly checked. With certain types of ICDs it is already possible to device remotely 24 hours a day. This will become possible with many more devices in the future.”

What can you do yourself to prevent problems?
“Ask the cardiologist if he maintains a registration system and if he wants to register you. If there are technical problems, he will know where to find you immediately.”

Stricter inspections in the future
Although all medical devices used in the Netherlands must have a so-called CE marking, this inspection is much less strict than that which medicines must comply with. A CE marking means that a product meets the minimum safety requirements of European regulations. It is also on vacuum cleaners and coffee makers. According to Schalij, the CE marking is not sufficient. “In fact, it just says that a device is safe right now. Whether that will still be the case in six or seven years, we don’t know.”

New implants are often only tested in the lab or on laboratory animals. Nevertheless, according to Schalij, it cannot always be prevented that implants are placed that have not yet been sufficiently tested on humans. “When new, better equipment comes on the market, you don’t want patients to have to wait six, seven years before they can benefit from it. Patients don’t want that themselves either.”

The professional associations of cardiologists, plastic surgeons, gynaecologists and orthopedic surgeons all advocate stricter inspections and have each also taken initiatives to increase safety.