Sprint Quattro Secure S Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Apr 2017 · 2 device variants grouped
Total Reports
1,985
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Impedance Warning on Defibrillation Coil
triggered, coil, defibrillation, use, use right
9
reports
Lead Integrity Alert Triggered by Noise
triggered, non, alert, use, integrity
7
reports
ICD System Explant Due to Infection
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
5
reports
T-Wave Oversensing on Right Ventricular Lead
oversensing twos, wave oversensing, use, use right, twos
4
reports
Undersensing on Right Ventricular Lead
episode, undersensing, observed right, use, use right
3
reports
High Thresholds on Right Ventricular Lead
high capture, stable condition, thresholds, exhibited high, use right
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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