CapSureZ Novus Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead) · First cleared Jun 1998 · 2 device variants grouped
Total Reports
839
Reports (30d)
4
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Premature Battery Depletion in IPG
implantable pulse, right ventricular, pulse generator, generator ipg, ipg
3
reports
Fracture and High Impedance in RV Lead
impedance, fracture, right ventricular, range, ventricular lead
2
reports
Far Field R-Wave Oversensing
ffrw, wave ffrw, field wave, wave, far field
2
reports
Low Impedance in RA Lead
undefined, use right, impedance lead, low impedance, oversensing lead
1
reports
Oversensing and Misclassification in RA Lead
event patient, patient complications, reported right, experienced, result event
1
reports
Undersensing During Atrial Events
tachycardia atrial, events, atrial fibrillation, undersensing atrial, atrial tachycardia
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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