Important Safety Alerts

Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its INGENIO, VITALIO, and ADVANTIO pacemakers and INLIVEN, INTUA, and INVIVE cardiac resynchronization therapy pacemakers (CRT-Ps).

The manufacturer has determined that dual chamber INGENIO family pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) built with Extended Life (EL) battery may transition to Safety Mode during interrogation attempts by either a programmer or a LATITUDE communicator.

Investigation has shown that the EL battery impedance increases over time, depending on implant duration and power usage. This increased battery impedance may cause a device to exhibit transient voltage decreases during periods of high-power consumption associated with telemetry communication via a programmer or a LATITUDE communicator. If the battery voltage drops below a minimum threshold during communication attempts, the device will temporarily halt telemetry, and a system reset will be performed. If three system resets occur within a 48-hour period, the device is designed to immediately enter Safety Mode to maintain back-up pacing with pre-defined, non-programmable settings. This mode is not intended to be a substitute for chronic pacing therapy and a replacement is required.

According to the manufacturer, no deaths are reported due to this issue. However, three cases were reported where patients received external pacing after Safety Mode was initiated.

The manufacturer is recommending affected users to take the following actions:

• Individual patient evaluation: When assessing potential risk for a patient if the device initiates Safety Mode prior to the Explant indicator, consider patient-specific physiological factors (which may vary over time), including: adequacy of underlying escape rhythm and/or the need for AV/VV pacing for cardiac synchrony and the potential for pacing inhibition due to myopotential oversensing.
• Replacement: If a device enters Safety Mode, schedule a replacement. Before this, the following guidance should be considered:
  • For EL pacemakers, if early replacement is planned, schedule replacement when the longevity remaining is 4 years (or less, if the device currently indicates fewer than 4 years longevity remaining).
  • For CRT-Ps, if early replacement is planned, schedule replacement when the longevity remaining is 3 years (or less, if the device currently indicates fewer than 3 years longevity remaining).
• Follow-up interval: Perform a system follow-up in clinic interrogation at least every 12 months. For patients who may not require early device replacement, continue with existing follow-up protocols until the longevity reaches One-Year-Remaining and then follow-up every three months thereafter until replacement is indicated.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 4 Jun 2021