Patient Safety Alert- Certain Medtronic Pacemakers and CRT-Ps (Azure, Astra, Percepta, Serena and Solara models)
Potential premature battery depletion of certain Medtronic implantable pacemakers and CRT-Ps (Azure, Astra, Percepta, Serena and Solara models)
On May 7, 2019, the U.S. Food and Drug Administration issued a safety communication to inform patients and health care professionals about the potential for the batteries of certain Medtronic implantable pacemakers to drain more quickly than expected and without warning to patients.
FDA also has issued an “FDA In Brief ” article.
At this time, preventative (prophylactic) removal and replacement of affected devices is not recommended. Rather, patients and professionals should carefully monitor battery status using home monitoring systems.
For additional information for healthcare professionals, Medtronic has issued a performance notes .