Linox Smart S DX 65/17 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Feb 2013
Total Reports
485
Reports (30d)
5
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explant Due to Oversensing and Shocks
lead capped, inappropriate, channel, oversensing, shocks
4
reports
Lead Capped for High Shock Impedance
patient events, received file, events reported, file updated, updated lead
1
reports
Lead Explant Due to Inappropriate Shocks
additional information, received file, file updated, updated lead, shocks
1
reports
Lead Explant Due to Noise and Impedance
patient events, events reported, file updated, updated lead, reported additional
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Sticherling C, et al. · Indian pacing and electrophysiology journal · 2018
Quartieri F, et al. · Indian pacing and electrophysiology journal · 2016
Why and When ICD Leads Are Extracted: Does the ICD Lead Model Influence Lead Survival?
Andrzej Kutarski, et al. · Medicina · 2025
Rationale and feasibility of the atrioventricular single-lead ICD systems with a floating atrial dipole (DX) in clinical practice
Máté Vámos, et al. · Trends in Cardiovascular Medicine · 2021
Citations indexed from PubMed.
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