Sprint Quattro Secure 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
4,902
Reports (30d)
41
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
19
reports
Right Lead Exhibited T-Wave Oversensing
oversensing twos, lead remains, wave oversensing, use, twos
15
reports
Lead Integrity Alert Triggered by Oversensing
triggered, non, alert, oversensing, integrity
14
reports
CRT System Explanted for Infection
resynchronization, cardiac resynchronization, crt, infection, therapy
9
reports
Extravascular ICD Explanted for Infection
icd, infection, patient complications, extravascular, result event
8
reports
High Thresholds with Loss of Capture
lead remains, thresholds, use, use right, capture
8
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Citations indexed from PubMed.
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