SQ-RX Pulse Generators 의 안전성 경고

Safety alert

2012-04-24

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20120425.html

Safety alert over cameron health sq-rx pulse generators the department of health (dh) has drawn public attention to a field safety advisory message relayed by the united kingdom medicines and healthcare products regulatory agency concerning the cameron health sq-rx pulse generator (model number 1010), after the manufacturer found that a limited subset of sq-rx pulse generators may enter an unexpected state under specific conditions, causing the device to reset repeatedly and render therapy unavailable. the pulse generator is a component of the cameron health s-icd system, which is an implantable cardioverter-defibrillator prescribed for patients when cardiac arrhythmia management is warranted. according to the advisory, which was spotted via dh's regular surveillance, the medical device manufacturer cameron health, inc. (cameron health) has confirmed one occurrence when a device entered the unexpected reset state and continuously emitted a series of audible tones. the patient concerned alerted the physician and the device was replaced without further complications. further investigation by the manufacturer indicated that this condition could be initiated in a limited subset of devices under specific conditions. no patient injury or death related to this condition has been reported so far. according to cameron health, the subset of devices that may exhibit this unexpected reset state are those initially shipped with software versions 2.1.135 or earlier and subsequently upgraded to version 2.3.308. cameron health records indicate that up to 323 devices worldwide could meet these criteria. no devices implanted after march 2011 are affected.   a programmer software update (version 1.90.0) is available to eliminate the possibility of this unexpected reset state occurring. while the dh is following up with the manufacturer on the supply of the device in hong kong, a spokesman urges patients who might have the affected device implanted to contact their physicians immediately should they notice an audible tone emitted from the device or should they have any queries. the department has alerted the hospital authority, private hospitals, relevant institutions and medical associations to the advisory. while the dh has not received any adverse report so far, the department will maintain vigilance and monitor the development of the issue. ends.