* An incident according to "§ 29 Medical device act or § 2 sec.1 Ordinance on Medical Devices Vigilance of Germany " is any malfunction, any failure or deterioration in the characteristics or performance of a medical device as well as any inaccuracy in the labelling or instructions for use which has led, or could have led, directly or indirectly, to the death or serious deterioration in the state of health of a patient or user or another person.