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www.fdanews.com/articles/137988-mhra-issues-medical-device-alert-for-implantable-cardioverter-defibrillator

MHRA Issues Medical Device Alert for Implantable Cardioverter Defibrillator

June 29, 2011
The Medicines and Healthcare products Regulatory Agency has used a medical device alert for Sorin Group’s implantable cardioverter defibrillator due to potential for pacing inhibition associated with ventricular oversensing if the follow-up monitoring feature, PhD, is turned on and the device is connected to high polarization defibrillation leads.