Linox Smart S DX 65/15 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Jul 2013
Total Reports
991
Reports (30d)
12
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Inappropriate Shocks from Oversensing
lead capped, inappropriate, channel, oversensing, shocks
6
reports
Noise on RV Channel Detected
received file, events reported, file updated, channel, remains implanted
3
reports
Lead Capped Due to Noise
patient events, lead capped, received file, events reported, file updated
3
reports
High Shock Impedance Measurement
received file, file updated, shock impedance, ohms, remains implanted
2
reports
Pocket Infection Leading to Explant
infection, received file, infection additional, pocket, file updated
2
reports
Lead Explanted Due to Dislodgement
file, received file, dislodgement, file updated, updated lead
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
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