The January recall of 48 Medtronic CRT-D and ICDs has now been expanded to include 752 additional devices at lower risk than those involved in the January recall,. There is an issue that occurred during the manufacturing process of these devices which could result in an unexpected loss of device functionality. If you have one of these devices, you should contact your doctor to discuss next steps.
You can see the advisory here.
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 you are affected, the search page would look like this:
This example shows that currently there are no advisories for my model.
As always, you can call Medtronic Patient Services with any questions at: (800) 551-5544 (M – F, 8am – 5pm Central)
Medtronic has recalled a small number of ICDs and CRT-D devices. A total of 48 devices implanted in patients may contain a manufacturing defect which would prevent the device from delivering an appropriate shock if needed.
This is a Class I recall, which is the most serious as determined by the FDA.
Physicians of record of those affected by the recall should have already been notified by Medtronic.
You can find a list of affected devices and serial numbers here.
You can also contact Medtronic Patient Services at 800-551-5544 (Monday-Friday, 8am-5pm Central Time).
Why MRI is Important:
Magnetic Resonance Imaging, or MRI, is one of the most important tools of modern medicine. MRIs can be used to evaluate almost every kind of medical issue, from brain tumors to twisted ankles. They provide clear images, and in some instances, also provide superior visualization. Because they do not expose the imaging subject to radiation, they are generally preferred over CT scans, even when the two scans would reveal the same information.
MRI in HCM:
In the last several years, MRI has also become an important tool in the evaluation of hypertrophic cardiomyopathy (HCM). The images resulting from MRI have proven superior in visualizing the size and structure of the heart and, when used with a contrast agent, MRIs are able to show the extent of scarring in the HCM heart.
MRI Hasn’t Been an Option for Many of Us:
MRI has been unavailable to those of us who have an implantable defibrillator or ICD to in order to protect us from sudden cardiac arrest. Until recently, having an ICD was an absolute contraindication to MRI. Newer MRI-safe ICD systems have been in use for the last few years, but that still leaves in place the contraindication for those of us who have older ICD units in place. That problem is that older lead systems that were implanted along with old, non-MR compatible generators may be incompatible with the newer MR compatible technology, and it may not be possible to simply hook up these old leads to a new MRI compatible generator. And, it is not as easy as you might think to extract old leads. Scar tissue grows around these leads, making their removal an intricate and dangerous procedure that is best done only in carefully controlled circumstances by highly specialized physicians. Continue reading “Yes We Scan! ICDs and MRIs”