SPRINT QUATTRO SECURE DXAC/DSP Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Implantable Cardioverter Defibrillator (ICD), Permanent Defibrillator Electrode (Lead) · First cleared Feb 2016 · 3 device variants grouped
Total Reports
5,724
Reports (30d)
0
Active Signals
0
Open Recalls
82
What the reports describe · Claripulse analysis
Most commonly reported problems
Impedance / Ventricular Lead / Pacing Impedance
lead remains, pacing impedance, impedance, high, ventricular lead
21
reports
Integrity / Lia / Alert Lia
integrity alert, lead integrity, alert lia, lia, integrity
13
reports
High Thresholds in RA Lead
noise, lead remains, lead exhibited, ventricular lead, oversensing
5
reports
Atrial Lead Exhibited High Thresholds
atrial, lead exhibited, remain use, atrial lead, use right
4
reports
Thresholds / Lead Exhibited / Ventricular Lead
lead explanted, lead remains, lead exhibited, thresholds, high
3
reports
CRT System Explanted for Infection
crt, infection, therapy, patient complications, result event
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Oct 29, 2025 · Open, Classified
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Evidence
Related research
Regoli F, et al. · BMC cardiovascular disorders · 2019
Alasti M, et al. · Journal of arrhythmia · 2018
Shikama T, et al. · HeartRhythm case reports · 2023
Kasai Y, et al. · Clinical case reports · 2024
Ferretto S, et al. · Journal of arrhythmia · 2019
Citations indexed from PubMed.
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