The lack of pacing could cause patients to experience a slow heartbeat, low blood pressure, or symptoms such as light-headedness, unconsciousness, and death.

No deaths were reported, but Medtronic said that 2 patients experienced a pause in pacemaking in a recall notice posted on the company website.

The recall involves Medtronic dual-chamber pacemakers that were distributed worldwide between March 10, 2017 and January 7, 2019 under the brand names Adapta™, Versa™ and Sensia™. Not all pacemakers within these brand-names are affected by this recall.

The issue occurs when the pacemakers are programmed to a dual-chamber mode with atrial-sensing. The device may be unable to provide pacemaking until a ventricular-sensed event is detected.

“Once a VS is detected, normal pacing functionality is restored immediately. If a VS is not detected, the device will withhold both atrial and ventricular pacing.”

Medtronic is developing a software update that can be installed into recalled devices to correct this issue. Medtronic estimates submission of this software update to regulatory agencies by the 2nd half of 2019.

Until the software update has been installed, Medtronic recommends programming the pacemaker to a non-susceptible pacing mode.

Medtronic also warned patients to seek immediate medical attention if experiencing any new or unexpected symptoms that are consistent with a pause in pacing.

Source: FDA gives massive Medtronic recall Class I designation

Posted by Daily Hornet

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