Medtronic (NYSE:MDT) recently issued a warning letter regarding an issue with its Linq II insertable cardiac monitors (ICMs).
Fridley, Minn.-based Medtronic’s warning informs users that Linq II ICMs that undergo a partial electrical reset appear to be programmed “ON,” but are no longer able to detect and report Brady, Pause and PVC events to clinicians.
The company said a partial electrical reset is considered normal behavior that can occur when the device detects a possible software issue, but an error in the partial electrical reset implementation causes the unintended behavior associated with the issue.
All Linq II ICM devices currently in distribution are susceptible to the issue, with 37 issue-related complaints received by Medtronic as of May 10, 2021. Complaint data suggests that the majority of the electrical resets were associated with electromagnetic interference (EMI) due to cardioversion or electrocautery.
When the issue occurs, Brady, Pause and PVC events will not be automatically collected, although the Patient Assistant will continue to function to manually trigger ECG collection, store the tracing and mark symptoms. Tachy and AT/AF detections remain unaffected by the reset.
Medtronic estimates that 0.21% of Linq II ICMs have experienced a partial electrical reset resulting in the inability to detect Brady, Pause and PVC events. The company said users should identify and quarantine all unused, affected Linq II ICMs before returning them to Medtronic.