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Sprint Fidelis Lead in the Sunday Mail 11 Dec 2011

9 December 2011

At all times patient safety is Medtronic’s top priority. As such we are committed to ensuring our products are of the highest quality and are processed through rigorous safety and technical assessment prior to distribution. However, no medical device or procedure, regardless of design, can be risk-free.

Medtronic is a clear industry leader in investing in long term monitoring studies and reporting those results for our products and responding quickly to provide information and recommendations to treating physicians and regulators where any issues are identified.

Medtronic Australasia is aware of and abides by, our obligations under TGA regulations. In the cases of Sprint Fidelis, Sigma and Kappa pacemakers, all actions have been undertaken in accordance with the TGA Uniform Recall Protocol for Therapeutic Goods (URPTG) guidelines and the TGA Adverse Events reporting requirements as per the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Patients should be assured that wherever issues are identified with products, doctors are provided with extensive information and recommendations in order to manage their patients appropriately. If patients have concerns with regards to their condition their doctor is the appropriate person to discuss these concerns.

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