CapSureZ Novus Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Sep 1986 · 2 device variants grouped
Total Reports
492
Reports (30d)
7
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Fractured Lead with High Impedance
impedance, high impedance, fracture, capped replaced, replaced right
2
reports
Far Field R-Wave Oversensing
exhibited far, ffrw, wave ffrw, field wave, ffrw oversensing
2
reports
High Impedance in Ventricular Lead
impedance, right ventricular, impedance lead, rising, ventricular lead
1
reports
High Impedance Triggering Alert
impedance, high impedance, range, low impedance, impedance lead
1
reports
Infection Leading to IPG Removal
implantable pulse, infection, pulse generator, generator ipg, ipg
1
reports
Infection Leading to Pacing Lead Explantation
infection, experienced infection, patient complications, complications, patient experienced
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
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