Linox Smart S DX 65/17 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Jul 2013
Total Reports
471
Reports (30d)
2
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explanted for Shock Impedance Issue
patient events, events reported, file updated, updated lead, reported additional
4
reports
Inappropriate Shocks from Oversensing
lead capped, inappropriate, channel, oversensing, shocks
2
reports
Lead Capped Due to Noise
patient events, events reported, file updated, updated lead, reported additional
1
reports
Lead Capped Due to Oversensing
monitoring, received file, lead capped, file updated, oversensing
1
reports
Lead Explanted for Under-Sensing
revision, dislodgement, leads, reported lead, explanted replaced
1
reports
Noise on RV Channel Detected
received file, events reported, file updated, channel, remains implanted
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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