The Abbott Park, Illinois-based company warned that a subset of Aveir VR LSP112V devices manufactured with firmware version 19.05.00 have the potential for electromagnetic interference that could cause an inadvertent mode change.
So far, the company said there have been no reports of permanent patient harm due to the issue. Two devices have been replaced due to early detection of the recommended replacement time (RRT).
The mode change can be detected during a Merlin programmer interrogation session, as the Aveir VR device could potentially be in Emergency VVI (EVVI) or MRI (VOO) mode. Since communication with the implanted Aveir requires a Merlin programmer, the issue can be detected at a scheduled in-clinic follow-up unless symptoms are present at an earlier evaluation, the urgent field safety notice said.
Abbott noted that the issue may cause an Aveir VR device to enter either EVVI or MRI mode. The parameters for EVVI mode are VVI pacing at 6 V @ 0.6 ms and 70 bpm, and MRI mode is VOO mode at 5 V @ 1 ms and 85 bpm. Compared to the nominal settings, the increased pacing output and rate of the modes may reduce the longevity of some leadless pacemakers.
Affected devices and recommendations from Abbott
Approximately 12,000 Aveir VR devices are subject to this notification with two patient effects reported. Four patients have reported the sensation of an elevated heart rate consistent with a mode change, according to Abbott. Two devices also showed early detection of RRT and were replaced.
Abbott estimates that 8% of the longevity of Aveir VR devices operating in MRI or EVVI mode is consumed for each month of operation.The service life of a device operating entirely in EVVI or MRI mode is approximately 13 months.
To mitigate the issue, Abbott said upgraded Merlin PCS 3650 programmer software will download new firmware version 19.12.00 for Aveir through an automatic prompt to the user during an in-clinic evaluation. All device settings and therapies will remain active during the firmware download.
The programmer software and updated firmware will be available to clinics this month.
Abbott does not recommend prophylactic device replacement. As part of the suggested three-month follow-up, Abbott recommends updating the Aveir VR’s firmware. For most devices, the upgrade should automatically download. If the device has shown to have been in MRI or EVVI mode, reprogram it to the desired mode and settings.
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