Simplifying Global Compliance
FDAnews Device Daily Bulletin
MHRA Issues Medical Device Alert for Implantable Pacemaker
Sept. 29, 2011
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert
for Medtronic Limited’s EnRhythm pacemaker. Following a software update, the new battery impedance elective replacement indicator (ERI) threshold may trigger an unexpected ERI in some devices.
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