LINQ II Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Insertable Cardiac Monitor (ICM/ILR) · First cleared Jul 2020 · 5 device variants grouped

Total Reports

9,526

Reports (30d)

174

Active Signals

3

Open Recalls

3

Monthly Report Volume
No timeline data available.
Event Type Breakdown
No event type data available.

Active safety signals

Disproportionate reportinghighDisproportionate reportinghighVolume spikemedium

FDA recalls for this device

Class II

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.

Class II

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.

Class II

May 14, 2021 · Open, Classified

Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.