Medical Device Advisory – How Should You Handle This?
I had an implantable cardioverter-defibrillator (ICD) implanted almost six years ago to prevent fatal arrhythmias from turning into cardiac arrest. It wasn't an easy decision at first, but I am happy to have this as a safety device as I have a low ejection fraction.
Last month, my device manufacturer issued an "Urgent Medical Device Correction", which listed my model, stating that they had identified a specific subset of devices that may experience a sudden battery drain due to the onset of an electrical short.
Seeing an advisory for your device can be incredibly alarming. We trust our ICDs to provide the necessary steps to perform when needed.
What is in a notice?
An advisory is issued when the manufacturer deems an identified issue as a potential concern. Issued advisories will describe the devices impacted, the problem, and the suggested actions.
Low battery notification
For this particular notice, it states a "Potential for Shortened RRT-to-EOS." This refers to the time between being notified that my battery is low and the time I have to replace the device. Typically, the battery alert will happen 4-6 months before the end of service or when the device needs replacement. This notice describes a situation where the 4-6 months could be shortened to days or weeks.
I know what to do
The stated recommendation is to continue with the local clinic protocols and routine interrogations. If I hear an audible tone, I would need to contact my clinic, and I would be scheduled for a box change (replacement of the ICD), or if they see this through my remote monitoring during the nightly transmission, they would call me.
Am I worried? No. It is important to understand that this notice doesn't state that my device will fail me; it will notify me of a problem that will allow me time to contact my care team and resolve the issue.
It is important to understand how your device is programmed and how it alerts you and your team if there is an issue. Each manufacturer has information via website and a customer service department that you can contact. You can also ask your clinic how your device is programmed along with the alerts.
There are different protocols to alert you to an issue. For Medtronic devices, there is an audible 30-second tone. For Medtronic devices, you can hear the tones here. If you participate in remote monitoring, the nightly downloads will notify your clinic/doctor of an issue.
I spoke with Doug Rachac, a former medical device company employee and current ICD patient and known patient advocate.
Better informed, less fear
He suggests first understanding if your device is involved in the advisory by checking with the website and entering your serial numbers. He also said to understand your device protocol and how to respond. He said, "patients have less anxiety and fear when they are better informed."
What I would do
Taking Doug's advice, I also asked my EP last week during a routine appointment. We reviewed the tones for my device and how and when they were alarm. We discussed this notice and what I would do.
If your device has an advisory notice:
- Understand the advisory/notice and if your device is included.
- Find out how your device will alert you if there is an issue.
- Find out what you should do and understand both the warnings and programmed frequency.
- If you hear a tone or another alert, call your clinic right away.
- Any questions, call your clinic and/or the customer service number of your device.
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