LINQ II Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Insertable Cardiac Monitor (ICM/ILR) · First cleared Jul 2020 · 5 device variants grouped
Total Reports
10,214
Reports (30d)
209
Active Signals
4
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Noise Complicating Episode Detection
fibrillation, noise, atrial, episodes, false
79
reports
Product Performance Issue Leading to Explant
explanted, insertable cardiac, adverse, effects, service
57
reports
Remote Monitoring Network Issues
monitoring network, marks, remote, counters, remote monitoring
56
reports
Early Recommended Replacement Time
rrt, recommended replacement, early, time rrt, replacement time
55
reports
Multiple Electrical Resets Experienced
use implantable, resets, electrical resets, resets icm, experienced multiple
35
reports
Signal Quality Noise Interference
change signal, noise, consistent minor, quality leading, device performing
27
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
Citations indexed from PubMed.
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 46,344 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 39,133 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 39,062 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 29,710 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,458 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,671 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 4 active signals detected right now.
Get Early AccessUnderstanding this data