InSync III Cardiac Resynchronization Therapy Pacemakers 의 안전성 경고

Safety alert

2015-11-11

2015-11-11

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20151111.html

Medical device safety alert: medtronic insync iii cardiac resynchronization therapy pacemakers medical device manufacturer, medtronic, has issued a medical device safety alert concerning its insync iii cardiac resynchronization therapy pacemakers (crt-p). the affected model numbers are 8042, 8042b and 8042u. the safety alert informs users of a long-term battery performance issue with insync iii crt-pacemakers. through 27 october 2015, the manufacturer has confirmed 30 devices (0.03%) worldwide that have been impacted by this issue, for which the root cause is unexpected high battery impedance. unexpected high battery impedance can result in the battery’s inability to supply sufficient electrical current, impacting device function. twelve (12) of the 30 devices had reports of unexpected loss of pacing capture. the other 18 devices experienced some form of erratic behavior, including early elective replacement indication (eri), significant fluctuations in remaining longevity estimates, and inaccurate lead impedances. through 27 october 2015, events associated with this issue have occurred in devices with implant durations of 53 months or more. the manufacturer has received one report of a patient death, where it is possible, but unconfirmed, that this issue was a contributing factor. if pacing capture is compromised, some patients may experience a return of heart failure symptoms due to loss of biventricular pacing. in cases involving pacemaker-dependent patients, a loss of pacing capture could result in serious injury or death. globally, there are approximately 22,000 active devices remaining, from an original implant population of 96,800. in the united states, just over 9,300 active devices remain. the manufacturer’s modeling predicts an estimated failure rate between 0.16% and 0.6% for the remaining active devices. according to the manufacturer, it is not possible to identify which devices might fail or when they might fail due to the unpredictable nature of this issue. the issue cannot be mitigated by programming changes or increasing patient follow-up frequency. insync iii crt-pacemakers are no longer distributed. current devices have a modified battery design that is not susceptible to this issue. the manufacturer offers the following patient management recommendations: prophylactic device replacement in non-pacemaker-dependent patients is not recommended. for pacemaker-dependent patients, physicians should carefully weigh the risks and benefits of device replacement to mitigate this issue on an individual patient basis. the estimated per patient mortality risk of this issue (0.007% to 0.02%) is comparable to the estimated per patient mortality risk of complications associated with an incremental, early device replacement (0.005%). continue routine patient follow up in accordance with standard practice, and advise patients to seek medical attention immediately if they experience new or unexpected symptoms. according to the local supplier, the affected products are distributed in hong kong. there have been no reports of adverse event in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 november 2015.