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
1,018
Reports (30d)
8
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Capped for Noise and Fracture
additional information, file, lead capped, file updated, updated lead
8
reports
Lead Explanted Due to Noise
patient events, events reported, file updated, updated lead, reported additional
6
reports
Lead Explanted for Oversensing and Shock
received file, lead capped, inappropriate, channel, oversensing
4
reports
Noise on Multiple Channels
additional information, received file, file updated, channel, remains implanted
4
reports
Template Summary: Infection Update
additional information, received file, infection additional, file updated
2
reports
Increasing Shock Impedance Observed
received file, file updated, shock impedance, ohms, remains implanted
2
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
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
A prospective, multicenter, randomized controlled trial comparing VDD-ICD with VVI-ICD in detecting subclinical atrial fibrillation in patients with ICDs: The Dx-AF trial
Mohammed Shurrab, et al. · Heart Rhythm O2 · 2024
Why and When ICD Leads Are Extracted: Does the ICD Lead Model Influence Lead Survival?
Andrzej Kutarski, et al. · Medicina · 2025
Citations indexed from PubMed.
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