LINQ II Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Insertable Cardiac Monitor (ICM/ILR) · First cleared Jul 2020 · 5 device variants grouped
Total Reports
10,005
Reports (30d)
232
Active Signals
1
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Multiple Electrical Resets Recorded
monitoring, experienced electrical, electrical, reset, electrical reset
169
reports
Premature Battery Depletion with Unknown Cause
insertable cardiac, adverse, icm device, effects, service
43
reports
Signal Quality Noise Interference
noise pattern, quality, signal quality, noise, performing intended
32
reports
Noise Affecting Episode Detection
use implantable, noise, episodes, episode, noted icm
32
reports
Rapid Abnormal Depletion at 21 Months
abnormal depletion, experienced rapid, rapid abnormal, rrt having, months noted
21
reports
Reached Replacement Time at 14 Months
recommended replacement, service, months, reached, replacement time
17
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
Kazemian P, et al. · Journal of arrhythmia · 2020
Utilization of remote reprogramming to manage insertable cardiac monitor arrhythmia alert burden
Amber Seiler, et al. · Journal of Cardiovascular Electrophysiology · 2024
Atta RM. · Health and technology · 2021
P‐Wave Oversensing by the Implantable Cardiac Monitor During Paroxysmal Atrioventricular Block: What Is the Mechanism?
Yuhei Kasai, et al. · Journal of Cardiovascular Electrophysiology · 2024
Laske TG, et al. · BMC physiology · 2014
Citations indexed from PubMed.
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