Reveal LINQ Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Insertable Cardiac Monitor (ICM/ILR) · First cleared Jul 2021
Total Reports
179
Reports (30d)
0
Active Signals
1
Open Recalls
3
Detection
Active safety signals
Regulatory
FDA recalls for this device
Nov 3, 2023 · Open, Classified
It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.
Jun 1, 2021 · Open, Classified
Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.
May 14, 2021 · Open, Classified
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
Evidence
Related research
Adverse events of subcutaneous loop recorders: Insights from the MAUDE database
Joseph Heaton, et al. · Pacing and Clinical Electrophysiology · 2022
Safety of in-hospital insertable cardiac monitor procedures performed outside the traditional settings: results from the Reveal LINQ in-office 2 international study.
Sanders P, et al. · BMC cardiovascular disorders · 2019
Citations indexed from PubMed.
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