The Accolade pacemaker system. [Image from Boston Scientific]

颂誉起搏器系统。[图片来自波士顿科学公司]

The FDA today issued a notice labeling the recall of

FDA今天发布了一项通知，标记为召回

Boston Scientific

波士顿科学公司

Accolade pacemaker devices serious as it may cause injury or death.

Accolade起搏器设备严重，因为它可能导致受伤或死亡。

Last December,

去年十二月，

Boston Scientific issued a voluntary notice

波士顿科学公司发布了自愿性通知

outlining issues with a subpopulation of Accolade, Proponent, Essentio and Altrua 2 dual-chamber standard life and dual-chamber extended life pacemakers and Visionist and Valitude cardiac resynchronization therapy pacemakers (CRT-Ps).

概述了Accolade、Proponent、Essentio和Altrua 2双腔标准寿命和双腔延长寿命起搏器以及Visionist和Valitude心脏再同步治疗起搏器（CRT-Ps）的子群体存在的问题。

Affected devices have an increased potential to initiate “Safety Mode” during telemetry or other normal, high-power operations. This occurs because of high battery impedance, underpowering the device system. The company attributed this to a manufacturing issue.

受影响的设备在遥测或其他正常高功率运行期间，有可能会启动“安全模式”。这是由于电池阻抗过高，导致设备系统供电不足。公司称这是由制造问题引起的。

Boston Scientific reported two deaths in pacemaker-dependent patients implanted with devices from the subpopulation of devices that initiated Safety Mode in an ambulatory setting. Today’s

波士顿科学公司报告称，在依赖起搏器的患者中，有两名患者植入了在门诊环境中启动安全模式的设备子群体中的设备后死亡。

FDA notice

FDA通知

disclosed 832 injuries related to the issue.

披露了832起与该问题相关的伤害。

The FDA said the recall — the most serious type — may involve the need for device explant. Using affected devices may cause serious adverse health consequences. Those include slow heartbeats (bradycardia), fainting (syncope) and death.

美国食品和药物管理局表示，此次召回属于最严重的类型，可能需要移除设备。使用受影响的设备可能会导致严重的健康后果，包括心跳过缓、晕厥甚至死亡。

More on the Boston Scientific recall

更多关于波士顿科学召回的信息

Safety mode, an intended feature, activates during critical component failures. If the affected device enters safety mode, early device replacement is required, the FDA notice said.

安全模式是一项预期功能，会在关键组件故障期间激活。美国食品药品监督管理局（FDA）的通知称，如果受影响的设备进入安全模式，则需要提前更换设备。

When the device experiences three power-on resets within 48 hours due to battery issues, it initiates safety mode. Once the device enters safety mode, it can’t be reversed and may cause the devices to provide only unipolar sensing and pacing. That can lead to serious injury or death due to interruption of pacing..

当设备由于电池问题在48小时内经历三次开机复位时，会启动安全模式。一旦设备进入安全模式，该过程不可逆，并可能导致设备仅提供单极感应和起搏功能。这可能会因起搏中断而导致严重伤害或死亡。

Boston Scientific previously said the potential for this issue increases when the device reaches approximately four years or less of remaining battery longevity. No devices within the advisory population remain available for implant. The company said in December that it plans to implement updated manufacturing work instructions for the process used to make cathodes for Accolade product batteries.

波士顿科学公司此前表示，当设备的电池寿命剩余大约四年或更短时，这个问题的可能性会增加。在建议范围内的所有设备均已不再用于植入。该公司在去年十二月表示，计划实施更新的制造工作指导，以改进用于生产Accolade产品电池的阴极制造工艺。

It also intends to develop a software update to detect battery health in all Accolade pacemaker devices..

它还打算开发一款软件更新，以检测所有Accolade起搏器设备的电池健康状况。

Users with Accolade devices should immediately have their device replaced if it enters safety mode and they’re at high risk of harm associated with interrupted pacing. The notice recommends non-urgent replacement for other patients. Users should not rely on battery life estimates in safety mode and should conduct system follow-ups (remote or in-office) at least once every 12 moths..

拥有Accolade设备的用户如果设备进入安全模式并且他们面临与起搏中断相关的高风险伤害，应立即更换设备。通知建议其他患者进行非紧急更换。用户不应依赖安全模式下的电池寿命估算，并应至少每12个月进行一次系统随访（远程或现场）。

What the company said when it initially warned on the pacemakers

公司最初对心脏起搏器发出警告时所说的话

A company spokesperson issued the following statement to

公司发言人发表了以下声明

MassDevice

大众设备

via email in December 2024:

通过电子邮件，2024年12月：

Boston Scientific voluntarily issued a product advisory involving a subset of specific types of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) because of the potential for these devices to transition to Safety Mode due to an elevated internal battery impedance. This behavior can occur later in device life and may require early replacement for some patients.

波士顿科学公司自愿发布了一份产品公告，涉及某些特定类型的起搏器和心脏再同步治疗起搏器（CRT-Ps），原因是这些设备可能由于内部电池阻抗升高而进入安全模式。这种行为可能在设备使用后期发生，并且可能需要对部分患者提前更换设备。

No devices within the advisory population remain available for implant..

在建议范围内，没有可用的设备可供植入。

Physicians following patients with devices included in the advisory population have been given recommendations intended to mitigate the risk of the behavior and will reach out to patients directly if a separate appointment should be made to assess their device.

针对建议中涉及的患者群体，医生已获得旨在减轻该行为风险的建议，并会在需要另行预约评估其设备时直接联系患者。