FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Medtronic Reports Issues With Micra Pacemaker

Sept. 12, 2019

Medtronic has issued a field safety notice for its Micra transcatheter pacing system, noting multiple complaints worldwide.

The devicemaker announced that 52 complaints for the tiny pacemaker, which is implanted directly in the heart, reported a tangled tether during tether removal that led to prolonged or additional procedures. The incidents did not lead to any reported deaths.

To address the issue, Medtronic is updating the product’s instructions for use to warn that flushing the delivery system after cutting the tether could cause the tether’s free end to enter the ventricular chamber and become tangled.

“Once the tether is cut, do not flush the delivery system until the tether has been fully removed,” the company advised.

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