China regulators warn on Micro-Pace pacemakers | MassDevice.com On Call
China's Dept. of Health issues a warning on dual-chamber temporary pacemakers made by Pace Medical.
MASSDEVICE ON CALL — China's Dept. of Health warned local healthcare providers of potential sensing issues noted in dual-chamber temporary pacemakers made by Pace Medical.
The warning involves Micro-Pace Model 4580 systems, programmable, multi-mode, multi-parameter cardiac pacemakers made by San Diego-based Pace Medica. The Micro-Pace devices also have FDA approval in the U.S.
"The manufacturer has had isolated reports of intermittent sensing issues with the affected product," according to the warning. "Under some circumstances, the affected device would fail to resume nominal sense operation once the programmed rate was lowered or became lower than the patients intrinsic rate."