Linox Smart S DX 65/15 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Feb 2013
Total Reports
1,029
Reports (30d)
11
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Capped for High Shock Impedance
patient events, received file, events reported, file updated, updated lead
8
reports
Lead Explant Due to Noise and Impedance
patient events, events reported, file updated, updated lead, reported additional
6
reports
Lead Explant Due to Oversensing and Shocks
lead capped, inappropriate, channel, oversensing, shocks
6
reports
Noise on Multiple Channels with Lead Remains
additional information, received file, file updated, channel, remains implanted
3
reports
Lead Explant Due to Inappropriate Shocks
additional information, received file, file updated, updated lead, shocks
2
reports
Explanted System Due to Infection
additional information, infection additional, file updated, monitored, explanted infection
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
Evidence
Related research
Safak E, et al. · Pacing and clinical electrophysiology : PACE · 2013
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
Percutaneous Simple Lead Traction Is a Feasible and Effective Method for Right Ventricular Lead Perforations
Hitoshi Mori, et al. · International Heart Journal · 2020
Citations indexed from PubMed.
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