MEDTRONIC, INC. · Insertable Cardiac Monitor (ICM/ILR) · First cleared Jul 2020 · 5 device variants grouped
Total Reports
9,002
Reports (30d)
219
Active Signals
2
Open Recalls
3
What the reports describe · Claripulse analysis
Early Recommended Replacement Time
recommended replacement, displayed early, time rrt, replacement time, rrt having
97
reports
False Pause Episode Due to Undersensing
noise, episodes, false, tachycardia, oversensing
94
reports
Signal Quality Noise Pattern
change signal, noise, leading consistent, pattern, pattern indicated
47
reports
Partial Electrical Reset Post-Cardioversion
patient cardioversion, electrical, reset, electrical reset, cardioversion
46
reports
Electrical Reset Event
resets, experienced electrical, reset icm, electrical, reset
44
reports
Electrical Reset with Monitoring Network Issues
monitoring network, remote, reset, network, remote monitoring
42
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
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
Monitoring of Remotely Reprogrammable Implantable Loop Recorders With Algorithms to Reduce False-Positive Alerts.
Neiman ZM, et al. · 2024
P-Wave Oversensing by the Implantable Cardiac Monitor During Paroxysmal Atrioventricular Block: What Is the Mechanism?
Kasai Y, et al. · 2024
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 2 active signals detected right now.
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