The FDA has announced a Class I recall of certain models of Medtronic implantable defibrillators and cardiac resynchronization therapy defibrillators. The statement from the FDA can be found here.
The recall impacts Medtronic’s Evera and Visia brands of ICDs as well as its Viva, Brava, Claria, Amplia and Compia brands of cardiac resynchronization therapy defibrillators (CRT-Ds) implanted from August 31, 2012 to May 9, 2018. The problem is described as “an unexpected and rapid decrease in battery life” caused by a short circuit. The defect may cause devices to go from recommended replacement time (when your alarm sounds to notify you that it is time to schedule a replacement surgery) to full battery depletion in just one day. Normally, you would have approximately 3 months from the time that the alarm first sounds to schedule a procedure to implant a replacement.
According to this article, there have been 444 complaints and 264 medical device reports about this issue which impacts 239,171 devices.
To look up your device by product name, model or serial number to see whether it is impacted, click here.
The box in the upper right corner labeled “Advisories For This Model” will tell you if there are any advisories for your device. If this particular recall affects your device, you will see the same advisory which is circled in red in the photo below.
Patients are advised to continue routine follow ups and use the Care Link Monitoring System.
And, as always, you can call Medtronic Patient Services with any questions at: (800) 551-5544
(M – F, 8am – 5pm Central).
HCM Beat 
Hi Cynthia. You are always so reliably helpful. Thanks for all you do. My husband has been in touch with Medtronic as he has one of the noted icd devices. I’m not sure what the terminology means. What is the difference between complaints and reports?
Best regards.
Ro
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Honestly not sure. No one has died from this problem though so that is good.
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I can answer that question! I worked for Medtronic’s Quality group for 5 years, which is the group where complaints are funneled for investigation. A “complaint” and a “report” are the same thing. They’re also called “product performance reports” internally. They are a record of any instance where the product doesn’t perform as designed, or where the user (doctor, patient, etc) is not happy with the performance of a product. That can range from just an odd harmless anomaly, to a serious potentially life threatening failure. All “complaints” are reviewed for severity and safety and are addressed as needed.
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Hi Cynthia! Great blog posting with excellent info. This issue affects my device, so I’ve been watching it closely. Your readers might be interested in the information I have learned (some of it, like the link to the serial # look-up is in your posting). Here is what I posted on a few patient support groups on Facebook:
On February 2nd, 2021 Medtronic issued a field advisory involving 339,000 ICDs and CRT-Ds. I will detail the issue below, but I’d like to point out that I am personally in the highest risk category listed in the advisory and I AM NOT WORRIED. You shouldn’t be either. But you should understand the issue, so let’s get started.
Special notes:
-ZERO PATIENTS HAVE HAD PERMANENT HARM OR HAVE DIED DUE TO THIS ISSUE.
– Of the 339,000 devices impacted by this advisory less than 0.5% will experience this issue. The other 99+% will be unaffected.
-This issue only impacts ICD and CRT-D devices implanted prior to February 2019. This issue does NOT impact BlueTooth enabled ICDs or CRT-Ds, or any device implanted after March 1, 2019.
-This issues also does NOT impact leadless pacemakers, 1 or 2 lead pacemakers, or CRT-P (3 lead pacemaker) devices. They utilize a different battery and are not included in this advisory.
-Doctors were informed of this issue starting February 3rd. Patients affected by this field action should start hearing from their clinics shortly via phone or mail.
To read the official advisory go to this link: http://wwwp.medtronic.com/productperformance/document.html?id=1450051&fbclid=IwAR1WTILH_SYyeVC6ZHGLOJxE8lAz0YaJXSIxhQmIYjrUyO6pRlwEmUZ_KM8
To look up your serial number and see if your specific device is included in the field action, go to this link: http://wwwp.medtronic.com/productperformance/serialLookup.html?serialNumber&fbclid=IwAR1O6yTI9kwwfB2T94IGdgu_zRdEtD7i6buTKS_ghv2O7zRbiMeWEJgHtpg
***After entering your serial number click “GO” and look at the box on the right-hand side titled “Customer Communications for this Device”. If you see a URL link there, click on it. If your device is affected by this issue you will see the title “Potential for Shortened RRT-to-EOS in Subset of ICDs and CRT-Ds”.
The Issue: Medtronic has identified an issue in a subset of devices that causes an electrical short within the device’s battery that quickly drains the remaining battery life. This brings the device to the Recommended Replacement Time (RRT) early and requires a speedy replacement. Devices that reach RRT naturally typically have 3-6 months of battery life remaining. Devices that reach RRT due to this issue have days to weeks of battery life remaining, from the day RRT is reached. The device will emit an audible tone daily once RRT is reached (see below). Patient’s devices that reach RRT due to this issue fall into two categories:
· Patients who require any level of pacing and/or receive 2 or more shocks per year should have their device replaced immediately
· Patients who do not require pacing, and/or whose device shocks less than 2 times a year should have their device replaced within a week
Devices that use more energy either through pacing, shocking, or a combination of the two, are less likely to experience this issue. Meanwhile, patients who do not require pacing, or who receive infrequent shocks will experience this issue at a slighter higher rate, but will be at a lower risk for injury or harm due to the low levels of therapy they typically receive.
This rapid battery depletion is not gradual. You will not see your device drop from 9 years of life remaining to 7 years, to 3 years over the course of 6-12 months. If this issue occurs a device would drop from, say, 4 years of life remaining to RRT in a matter of days or weeks, possibly within one day. Your first indication of an issue would be hearing the audible alert (see below), or your doctor contacting you because of an automatic remote Carelink transmission.
Current recommendations are to continue remote monitoring (if available), and to familiarize yourself with the High-Urgency alert tones Medtronic ICDs and CRT-Ds emit when issues are discovered, such as a device reaching RRT. You can hear the “high-low” tone at the 40 second mark of this video: https://www.youtube.com/watch?v=u82zUPw8Ac4 If you hear this tone, contact your doctor’s office the same day you first hear the tone.
Patients who experience this issue will hear the 30-second High-Urgency (high-low) alarm on the day their device reaches RRT. They will then hear that same 30-second high-low tone every day at the same time until they are able to have the device interrogated or replaced. For those patients who are remotely monitored, once RRT is reached the device will immediately begin searching for your bedside monitor in order to send a remote monitoring report to your doctor. Patients who hear the High-Urgency alert, especially those who are not remotely monitored, should contact their doctor’s office immediately and follow their instructions.
It is NOT recommended that you have your device replaced prior to the device reaching RRT.
A subset of the following product families are affected:
Amplia
Brava
Claria
Compia
Evera
Visia AF
Viva
Key takeaways:
-If you hear a high urgency tone contact your clinic.
-A VERY small percentage of patients will experience this issue (~0.5%).
-Those at the highest risk of experiencing this issue are those patients who use/need their device the least (those with no/low pacing, no/low shocks).
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