Linox Smart SD 65/16 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
510
Reports (30d)
2
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Shock Impedance Measurement
received file, file updated, shock impedance, ohms, remains implanted
2
reports
Inappropriate Shocks from Oversensing
lead capped, inappropriate, channel, oversensing, shocks
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 44,929 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 37,761 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 37,430 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 28,090 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 19,969 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,531 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. 1 active signal detected right now.
Get Early AccessUnderstanding this data