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)
20
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Out-of-Range Defibrillation Impedance
triggered, impedance, coil, use, use right
10
reports
Lead Integrity Alert Triggered by Oversensing
triggered, non, alert, oversensing, integrity
7
reports
Right Lead Exhibited T-Wave Oversensing
oversensing twos, lead remains, wave oversensing, use, twos
6
reports
Right Lead Exhibited Undersensing
episode, lead remains, undersensing, use, use right
6
reports
CRT System Explanted for Infection
resynchronization, cardiac resynchronization, crt, infection, therapy
3
reports
High Thresholds with Loss of Capture
lead remains, thresholds, use, use right, capture
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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