Sprint Quattro Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Jan 2016
Total Reports
1,707
Reports (30d)
567
Active Signals
3
Open Recalls
82
What the reports describe · Claripulse analysis
Most commonly reported problems
Rising Defibrillation Impedance in RV Lead
lead remains, pacing impedance, impedance, lead exhibited, use right
56
reports
RV Lead Integrity Alert Triggered
integrity alert, lead integrity, alert lia, lia, integrity
42
reports
T-Wave Oversensing in RV Lead
oversensing twos, lead remains, wave oversensing, lead exhibited, use right
26
reports
CRT Device Explanted for Infection
crt, infection, patient complications, patient experienced, result event
14
reports
RV Lead Undersensing Observed
episode, lead remains, undersensing, lead exhibited, use right
9
reports
Helix Extension Failure During Implant
observed, coil, lead exhibited, appeared, showed
8
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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
Failure rates of single- versus dual-coil nonrecalled sprint quattro defibrillator leads.
Shariff N, et al. · The American journal of cardiology · 2014
Transvenous Implantable Cardioverter-Defibrillator (ICD) Lead Performance: A Meta-Analysis of Observational Studies.
Providência R, et al. · Journal of the American Heart Association · 2015
Early ICD lead failure in defibrillator systems with multiple leads via cephalic access
Chirag R. Barbhaiya, et al. · Journal of Cardiovascular Electrophysiology · 2020
Failure-free survival of the Durata defibrillator lead.
Liu J, et al. · Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2013
Internal insulation breaches in an implantable cardioverter-defibrillator lead with redundant conductors.
Hauser RG, et al. · Heart rhythm · 2019
Citations indexed from PubMed.
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