Tag: crt-d

Medtronic ICD and CRT-D Recall

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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 348,616 devices implanted between October 13, 2017 to June 9, 2023 with the following models being affected:

  • Cobalt XT, Cobalt, Crome ICDs and CRT-Ds
  • Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds
  • Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs

These devices fail to deliver therapy due to inappropriate activation of the Short Circuit Protection feature. The issue is more likely to occur for devices with a glassed feedthrough that are configured to deliver therapy in the AX>B delivered pathway.

A reduced-energy shock, or no shock at all, may fail to correct a life-threatening arrhythmia, which can lead to cardiac arrest, other serious injury, or death.

There have been 28 incidents, 22 injuries, and no deaths for this issue.

A software update delivered to your device will address the issue.  This requires a visit to your health care practitioner for a quick update. I had mine updated in a quick 10 minute visit to my ICD clinic.

To look up your device by product name, model or serial number to see whether it is impacted, click here.

NOTE:  You can find the name, model and serial number of your device on the plastic identification card provided to you at the time of your implant.

medtronic pic from website revised
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The box in the upper right corner labeled “Customer Communications 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).

Medtronic ICD Recall

Published on by hcmbeatLeave a comment

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.

Continue reading “Medtronic ICD Recall” →

Medtronic ICD Recall

Published on by hcmbeat4 Comments

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.

Medtronic recall 1

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).

Medtronic ICD Advisory Expanded

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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:

Hugo MDT

This example shows that currently there are no advisories for my model.

Protecta MDT page

As always, you can call Medtronic Patient Services with any questions at: (800) 551-5544 (M – F, 8am – 5pm Central)

 

 

Limited Recall of Medtronic ICDs and CRT Devices

Published on by hcmbeat2 Comments

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).