CRYSTALLINE ACTFIX Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)
Total Reports
387
Reports (30d)
3
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Undersensing During Atrial Events
event patient, patient complications, tachycardia, patient experienced, result event
2
reports
Far Field R-Wave Oversensing
wave ffrw, field wave, wave, far field, oversensing
1
reports
High Thresholds in RA Lead
thresholds lead, lead capped, exhibited high, replaced right, high thresholds
1
reports
Oversensing and Noise in Both Leads
noise, remain use, right ventricular, leads, oversensing
1
reports
Polarity Switch in RV Lead
impedance, polarity switch, right ventricular, use right, ventricular lead
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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