Loading...
Loading...
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
There were reports of an increase in reactive negative controls and false positive results.
There were reports of an increase in reactive negative controls and false positive results.