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).
In this study just published in the Heart Rhythm journal of the Heart Rhythm Society, doctors demonstrated that an Apple iPhone 12 (which is built with more magnets than previous iPhone models due to the Mag Safe charging technology) can disable the ability of an implantable defibrillator to deliver therapy.
So, this is a reminder for ICD patients that according to all device manufacturers, in order to avoid a problem, keep your phone at least 6 inches away from your device, and remember that you should NEVER PUT YOUR PHONE (ANY PHONE, NOT JUST AN IPHONE 12) IN YOUR SHIRT POCKET!
If you are looking for a good survey of current practices in the treatment of HCM, a recent article published in the journal Structural Heart by Dr. Ahmad Masri and the team at Oregon Health and Sciences University (OHSU) provides an informative overview of thirty controversies and considerations in the treatment of HCM. This article explains in some detail how the doctors at this HCM Center approach these situations.
Continue reading “HCM Treatment: The View from OHSU”
According to a recent paper published in Circulation, children’s risk for sudden death should be evaluated using different risk factors than those used for adults.
Two main differences seen between factors influencing the risk of sudden death of children and adults were that:
- for children, family history of sudden death was not a risk factor;
- a left ventricular outflow tract gradient in a child suggested a lower risk of sudden death.
The authors of this study propose that the risk assessment factors highlighted in this study (and not the various risk assessment tools that have been developed for adults) should be used by clinicians to evaluate the need for implantable defibrillators in children.
Dr. Stephen Heitner, together with his colleagues at Oregon Health & Sciences University, published an article last week in the European Journal of Heart Failure which gives a glimpse into the treatment of hypertrophic cardiomyopathy (HCM) in the future. Although recent publications have stated that the majority of HCM patients today have a favorable prognosis when receiving appropriate treatment, a heavy disease burden continues to be placed upon patients. Hence, better and more effective treatments for HCM are still needed in order to lessen this burden.
Continue reading “The Future of HCM Care”
Here is an informative new video from our friend Doug Rachac that nicely explains the safety of MRIs for patients with implantable defibrillators and pacemakers.
I wrote a blog piece about this same issue a few years back. Here it is:
Yes We Scan! ICDs and MRIs
And a few other relevant blog entries here on HCMBeat:
Study Shows MRIs Safe for Pacemaker & ICD Patients
Chapter 3: MRI Safety for ICD & Pacemaker Patients
Safety of MRIs With Abandoned Leads
Last year, Doug wrote this blog entry for HCMBeat specifically about magnets and airports. Read that here:
Blogger Doug Rachac – Magnets and Airports: Should ICD Patients Be Afraid?
And, you can find more about ICDs from Doug on his YouTube Channel.
This informative blog article written by a social worker for the University of Michigan’s Health Blog has some great tips on how to deal with anxiety when living with an ICD.
I recommend it.
According to a paper published last week in JAMA Cardiology, doctors at Tufts University’s HCM Center have been able to identify 95% of their patients at high risk of sudden cardiac death (SCD) from HCM. Tufts applied an updated and modified version of the risk factors enumerated in the American College of Cardiology/American Heart Association Guidelines promulgated in 2011.
Continue reading “Docs Reliably Identify HCM Patients in Need of ICDs”
This story in the Wall Street Journal about genetic testing shows the speed of changes in the medical community’s understanding of how and whether certain genes cause hereditary disease.
The article quoted Dr. Jodie Ingles, a geneticist from the University of Sydney in Australia who specializes in HCM and has published a recent article on the subject. Dr. Ingles said that 22 out of 33 genes comprising a genetic testing panel commonly used to test for HCM had either limited or no evidence of being disease causative.
Continue reading “Wall Street Journal Highlights Risks in Genetic Testing”
Today, it was announced by the U.S. Department of Homeland Security that 750,000 implantable defibrillators manufactured by Medtronic could potentially be vulnerable to hacking.
Continue reading “Hackers and ICDs: What to Know About Today’s Medtronic Warning”