Linox Smart SD 65/16 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
513
Reports (30d)
2
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explanted for Oversensing and Shock
received file, lead capped, inappropriate, channel, oversensing
3
reports
ICD High Shock Impedance Measurements
measurements, icd, shock, shock impedance, range shock
1
reports
Increasing Shock Impedance Observed
received file, file updated, shock impedance, ohms, remains implanted
1
reports
Lead Capped for Noise and Fracture
additional information, file, lead capped, file updated, updated lead
1
reports
Noise on Multiple Channels
additional information, received file, file updated, channel, remains implanted
1
reports
RV Lead Capped Due to Noise
file, patient events, events reported, 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
Kowal JL, et al. · HeartRhythm case reports · 2020
Three-Dimensional Analysis of the In Vivo Motion of Implantable Cardioverter Defibrillator Leads
Tamás Szili‐Törok, et al. · Cardiovascular Engineering and Technology · 2021
Citations indexed from PubMed.
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