News and Educations

Safety information about LIFEPAK 12 defibrillator/monitor of the manufacturer Physio–Control Inc.

10.04.2009

Medic d.o.o., representative of the manufacturer Physio–Control Inc., USA, a Medtronic Group member, notified the Agency for Medicinal Products and Medical Devices of a defective printed board of a LIFEPAK 12 defibrillator/monitor component. This defect may cause a short circuit on the component, which may result in no therapy delivery or in delivery of inadequate defibrillation waveforms. There have been no reported adverse events due to this defect.
The representative has notified all users and organised the replacement of the incorrect printed boards with new ones.

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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 representative undertook to provide all users of the Sprint Fidelis electrodes with additional information within the shortest time possible.

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Withdrawal of the Architect reaction vials manufactured by Abbott Laboratories, USA

06.03.2009

The representative of the manufacturer Abbott Laboratories of USA, Abbott Laboratories d.o.o. notified the Agency for Medicinal Products and Medical Devices about the withdrawal of certain series of the Architect reaction vials. When using the specified series of the Architect reaction vials, a discharge of static electricity can occur.

The representative notified all users not to use the reaction vials carrying specified serial numbers and initiated the procedure for withdrawal of the product from the market.

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Letter to physicians concerning the early termination of the LIBERATE clinical study

03.03.2009

In cooperation with the Agency for Medicinal Products and Medical Devices, Shering Plough d.o.o. sent a letter to physicians concerning the early termination of the LIBERATE clinical study due to a significant increase in risk of the breast cancer relapse in the group of study subjects taking the active substance tibolone in comparison with the group taking the placebo.

This clinical study has not been implemented in the Republic of Croatia.

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