Linox Smart SD 60/16 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
347
Reports (30d)
1
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Capped Due to Noise
lead capped, received file, file updated, updated lead, shocks
2
reports
High Shock Impedance Measurement
received file, file updated, shock impedance, ohms, remains implanted
1
reports
Lead Explanted for Shock Impedance Issue
patient events, events reported, file updated, updated lead, reported additional
1
reports
Pocket Infection Leading to Explant
infection, received file, infection additional, pocket, file updated
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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