BOSTON SCIENTIFIC CORPORATION · Permanent Pacemaker Electrode (Lead) · First cleared Nov 1998 · 3 device variants grouped
Total Reports
2,419
Reports (30d)
23
Active Signals
3
Open Recalls
0
What the reports describe · Claripulse analysis
Noisy Signals and Low Impedance in Atrial Lead
adverse, effects, reported right, range, service
16
reports
Infection Leading to RV Lead Explant
lead explanted, infection, effects, revision, additional adverse
8
reports
Infection Leading to Lead Explant
lead explanted, infection, revision, effects, additional adverse
7
reports
High Pacing Thresholds in Ventricular Lead
adverse, effects, reported right, additional adverse, ventricular lead
5
reports
Noise on Stored Ventricular Episodes
noise, adverse, effects, service, ventricular lead
4
reports
Inappropriate Therapy Delivery by CRT-D
crt, therapy, defibrillator, tachycardia, ventricular tachycardia
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Long-term performance of an atrial lead capable of accelerometer based detection of cardiac contractility in patients receiving cardiac resynchronisation therapy.
Senoner T, et al. · 2019
Early Tracheostomy Change in Neonates: Feasibility and Benefits.
Zebda D, et al. · 2021
Global predictors of tracheostomy-related pressure injury in the COVID-19 era: A study of secondary data.
Moser CH, et al. · 2024
Airway findings in children with tracheostomies: When is diagnostic bronchoscopy and laryngoscopy indicated?
Sharif-Askary B, et al. · 2018
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 3 active signals detected right now.
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