MHRA has updated a 2012 medical device alert for Quicksite and Quickflex devices manufactured by St. Jude Medical, recommending discontinuation of prophylactic replacement.
Certain models with damaged lead insulation could potentially worsen heart failure symptoms after implantation.
MHRA recommends that cardiologists and cardiac physiologists return patients to a six month follow-up period, and withdraw certain models and remotely monitor patients in collaboration with St. Jude.
The April 2012 alert advised UK hospitals not to implant QuickSite and QuickFlex leads, and to follow up every three months on all patients already implanted with these leads.
Read the updated alert here: www.fdanews.com/06-23-16-MHRALeadAlert.pdf.