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My heart doesn't beat well. At least, it doesn't beat well on its own. I have a one hundred percent heart block. This a problem with my heart's electrical system and not a problem with my arteries. I'm not concerned about having a heart attack. What threatens me is heart failure. You see, on its own my heart would beat only about 30 times a minute, maybe even less. Without my pacemaker, my ankles would swell, fluid would gather in my gut and surround my heart. My lungs would fill with fluid and I'd have a difficult time breathing. Within days I'd be dead.
My pacemaker is an implanted medical device attempting to partially correct my heart's electrical system failure. It is not a perfect solution and there are problems associated with having one implanted. How anyone could think that having a chunky metal box inserted into one's chest and attached to one's heart by 26-inches of wire could possibly be risk-free puzzles me.
CBC is reporting that tens of thousands of medical devices distributed worldwide — like pacemakers — were approved for sale with little scientific evidence . . .
CBC claims devices such as pacemakers are suspected of having played a role in more than 14,000 reported injuries and 1,416 deaths. This number is so large because it includes problems associated with a number of devices, of which pacemakers are but one.
I discovered 157 deaths and 1,291 patient injuries are associated with pacemakers. This is not all that surprising when the complexities of the system and the all-too-clear dangers are considered.
Simply making a pocket in a patient's chest and inserting a metal box is fraught with danger: infection, blood clots, stroke and the list just grows. And, if a problem does arise, the solution may well demand another operation. Surgery is never risk free.
What did surprise me were some of the incidents that made the list. I admit to cherry picking but this is my point. Don't just take the numbers and other bits of information at face value.
The CBC encourages us to question the motives of the device makers. The manufacturers may be driven by a need for profit. I suggest the CBC, and all news folk, should face questions as well. Journalists may have their own demons driving them forward. Think viewers, readers, awards and even think profits. I like to think it's the demand to tell a good story that blinds them.
So what were the surprising incidents that made the pacemaker incident list? Here are a few:
- patient piloting air ambulance involved in plane crash died. no evidence to support a device-related cause for the event.
- generator and associated leads were removed due to infection. source of infection unknown. patient died from liver cirrhosis.
- patient died due to acute coronary artery disease. device tested and functioned properly and within specification. patient was 85.
- pacemaker implanted for heart block. developed non-ischemic cardiomyopathy with ejection fraction diminishing. root cause was physiological.
Now maybe a good time to read the CBC fine print:
- CBC has not verified the accuracy of the data.
- Reports might have been filed to Health Canada with inaccurate or incomplete information.
- There is no certainty that the medical device caused the reported reaction.
- A given reaction may be the result of an underlying disease, process or another coincidental factor. One report may be tied to multiple parts of the same device and multiple reactions may be connected to a single patient.
The data does not reflect any CBC assessment of association between the health product and the reaction(s).
I'm on my second pacemaker. I got seven years out of my first unit before the battery failed. I apparently suffered no infection from the replacement surgery. My luck seems to be holding. But, I cannot be completely certain I escaped the threat of infection until a full year has passed.
My original lead, the 26-inch wire connecting my pacemaker to my heart, was retained and reused. It has now been operating in a very hostile environment, the human body, for eight years. How long that lead will last is anyone's guess. The electricity-conducting wire could corrode or succumb to metal fatigue. Leads do fail and the frequency increases with time. And, of course, there is always the threat of manufacturing defects and recalls.
Just living carries risks. I simply live with a few extra risks. But risks in life are often nicely balanced by rewards. I believe the risk/reward ratio associated with my pacemakers are weighted heavily in favour of my pacemakers.
Thank you Medtronic.
Despite the scary tone of some of the CBC reporting concerning pacemakers, the ICIJ stories, the source for the ongoing CBC reports, is often not as frightening. The ICIJ is actually fairly reasonable. The following is from the ICIJ report titled: Frequently asked questions and resources for readers.
Do all medical devices have problems?
No. For example, pacemakers and implantable cardioverter defibrillators (ICDs) have revitalized and saved millions of lives.
I'm not keen on having man-made stuff implanted into my body. I've had car problems, microwave breakdowns and expensive camera battery failures. Stuff fails. It is a fact of life. Sadly, sometimes stuff fails because of poor design or shoddy workmanship. This is not acceptable in any situation but it is a worst case scenario when it involves the failure of a medical device. The ICIJ is doing us all a service.
The ICIJ asks who is watching the medical device makers? I wonder who is watching the journalists?
