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
503
Reports (30d)
6
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Pacing Lead Dislodged and Replaced
explanted, pacing lead, lead explanted, replaced, lead dislodged
2
reports
IPG Explanted Due to Infection Post Replacement
generator, infection, pulse generator, ipg explanted, ipg
2
reports
RA Lead Exhibited Noise Detected
noise, waves, exhibited noise, atrial fibrillation, use right
1
reports
RA Lead High Impedance Detected
impedance, high impedance, switch, exhibited high, replaced right
1
reports
RA Lead Low Impedance Detected
impedance, range, use right, low impedance, impedance lead
1
reports
IPG Explanted Due to Infection
implantable pulse, infection, pulse generator, ipg explanted, generator ipg
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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