Additional information on the Sprint Fidelis electrodes manufactured by Medtronic
17.03.2009
An additional information concerning the Sprint Fidelis electrodes was submitted to the Agency for Medicinal Products and Medical Devices by MEDIC d.o.o., representative of the manufacturer Medtronic. The information is linked to the prior withdrawal of the Sprint Fidelis electrodes in 2007. The additional information concerns provision of care to the patients who had such electrodes already implanted and now require intervention–a replacement or an upgrade.
Three such electrodes have been delivered and implanted in the Republic of Croatia. The representative undertook to provide all users of the Sprint Fidelis electrodes with additional information within the shortest time possible.
