The FDA has introduced a Class I recall of sure fashions of Medtronic implantable defibrillators and cardiac resynchronization remedy defibrillators. The assertion from the FDA will be discovered right here.
The recall impacts 348,616 units implanted between October 13, 2017 to June 9, 2023 with the next fashions 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 units fail to ship remedy because of inappropriate activation of the Brief Circuit Safety characteristic. The difficulty is extra more likely to happen for units with a glassed feedthrough which might be configured to ship remedy within the AX>B delivered pathway.
A reduced-energy shock, or no shock in any respect, could fail to right a life-threatening arrhythmia, which might result in cardiac arrest, different severe damage, or demise.
There have been 28 incidents, 22 accidents, and no deaths for this difficulty.
A software program replace delivered to your machine will tackle the difficulty. This requires a go to to your well being care practitioner for a fast replace. I had mine up to date in a fast 10 minute go to to my ICD clinic.
To search for your machine by product identify, mannequin or serial quantity to see whether or not it’s impacted, click on right here.
NOTE: You’ll find the identify, mannequin and serial variety of your machine on the plastic identification card supplied to you on the time of your implant.
The field within the higher proper nook labeled “Buyer Communications For This Mannequin” will inform you if there are any advisories on your machine. If this explicit recall impacts your machine, you will note the identical advisory which is circled in crimson within the picture under.
Sufferers are suggested to proceed routine comply with ups and use the Care Hyperlink Monitoring System.
And, as all the time, you may name Medtronic Affected person Companies with any questions at: (800) 551-5544
(M – F, 8am – 5pm Central).