Lumax 740 VR-T Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Implantable Cardioverter Defibrillator (ICD) · First cleared Jul 2013
Total Reports
246
Reports (30d)
4
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Replaced Due to ERI Status
battery, additional information, stable, explanted replaced, remains implanted
5
reports
Battery Behavior at ERI Indication
battery, additional information, clinic, device remains, remains implanted
1
reports
Stable Device with Noise Oversensing
reprogramming, stable, oversensing, contacted, technical
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Ishibashi K, et al. · Journal of arrhythmia · 2017
Uehara Y, et al. · Journal of cardiovascular electrophysiology · 2025
Afzal MR, et al. · HeartRhythm case reports · 2017
Wörmann J, et al. · Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024
Afzal MR, et al. · Heart rhythm · 2017
Citations indexed from PubMed.
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