CapSureSP Novus Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead) · First cleared Sep 1986 · 6 device variants grouped
Total Reports
651
Reports (30d)
4
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Impedance in RV Lead
impedance, right ventricular, impedance lead, rising, ventricular lead
1
reports
IPG Explanted Due to Infection
pulse, implantable pulse, infection, pulse generator, ipg explanted
1
reports
Lead Capped and Replaced
lead capped, impedance, lead reprogrammed, reported lead, explanted
1
reports
Oversensing and Misclassification in RA Lead
noise, resulting misclassification, episode, misclassification episode, misclassification
1
reports
Oversensing and Noise in Both Leads
noise, remain use, right ventricular, leads, oversensing
1
reports
Oversensing Triggering False Detections
exhibited far, triggering, field wave, far field, oversensing triggering
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Serge Barold S, et al. · Herzschrittmachertherapie & Elektrophysiologie · 2016
Crossley GH, et al. · Pacing and clinical electrophysiology : PACE · 2019
Noheria A, et al. · Indian pacing and electrophysiology journal · 2015
Maeda S, et al. · Journal of clinical medicine · 2022
Citations indexed from PubMed.
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