Paradym DR 8550, CRT 8750 and CRT sonR 8770 의 안전성 경고

Safety alert

2010-06-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20100615.html

Software defect may cause malfunction in implantable cardioverter-defibrillator the department of health (dh) today (june 9) received notification from a local supplier, innotronik hong kong limited (innotronik), about a software problem in three models of implantable cardioverter-defibrillators (icds) manufactured by sorin in italy. the affected 3 models are paradym dr 8550, crt 8750 and crt sonr 8770. the problem is due to a rare software anomaly when dual-chamber backup pacing (i.E.Pacing to both heart atrium and ventricle) is applied. according to the supplier, approximately 2,800 units have been implanted worldwide. as of 7 june this year, sorin has received one confirmed report of defect. no patient injury or death has occurred as a result of the identified software anomaly. according to innotronik, a software update will eliminate this risk. the new software will be updated to the patient's icd in the next scheduled check-up. innotronik informed that three paradym dr 8550 icds have been implanted as single chamber backup pacing in hong kong. the risk of these patients being affected by this software anomaly is low. innotronik has set up a hotline (tel no. 2877 6787) for enquiries. a dh spokesman reminded patients with implanted icds that they should seek medical attention immediately if they felt unwell. meanwhile, the dh will inform public and private hospitals, medical associations and healthcare professionals and will also follow up with innotronik on further developments, if any. ends/wednesday, june 9, 2010.