CAPSURE Z NOVUS Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead) · First cleared Jun 1998 · 2 device variants grouped
Total Reports
2,182
Reports (30d)
27
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Ventricular T-Wave Oversensing with Atrial Low Impedance
remain use, wave, low impedance, use right, oversensing
4
reports
Pocket Infection Requiring System Replacement
implantable pulse, event patient, pocket infection, generator ipg, ipg
3
reports
Ventricular Undersensing Causing Inappropriate Pacing
pacing lead, exhibited undersensing, undersensing, event patient, patient complications
3
reports
Atrial Low Impedance with Ventricular High Thresholds
impedance, remain use, remain, leads, exhibited high
2
reports
Ventricular High Thresholds with Dizziness
event patient, patient complications, experienced, patient experienced, result event
2
reports
Infection with Generator Explant, No Replacement
developed infection, implantable pulse, event patient, patient developed, generator ipg
2
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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