Sprint Quattro Secure S DXAC/DSP Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Jan 2019 · 2 device variants grouped
Total Reports
480
Reports (30d)
6
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
RV Lead T-Wave Oversensing Observed
oversensing twos, wave oversensing, right ventricular, ventricular lead, twos
2
reports
Lead Integrity Alert Triggered
integrity alert, lead integrity, alert lia, lia, integrity
1
reports
RV Lead High Capture Thresholds Observed
lead exhibited, thresholds, use right, ventricular lead, capture
1
reports
CRT-D System Explanted Due to Infection
crt, infection, therapy, patient complications, result event
1
reports
RV Lead High Pacing Impedance Observed
lead remains, pacing impedance, lead exhibited, right ventricular, ventricular lead
1
reports
RV Lead Suspected Fracture Observed
lead explanted, fracture, voltage, right ventricular, ventricular lead
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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