Boston Scientific Corporation: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

Hazard

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

Details from the source

Reason for recall: For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location. Distribution: Worldwide distribution - US Nationwide and the country of Belgium. Quantity: 2 units Lot/code info: LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787

UPC codes

00802526620713

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.