Sprint Quattro Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Jan 2016
Total Reports
1,159
Reports (30d)
9
Active Signals
1
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
9
reports
Integrity / Lia / Alert Lia
integrity alert, lead integrity, alert lia, lia, integrity
4
reports
High Thresholds in RA Lead
noise, lead remains, lead exhibited, ventricular lead, oversensing
2
reports
Thresholds / Lead Exhibited / Ventricular Lead
lead remains, lead exhibited, thresholds, use right, ventricular lead
2
reports
ICD System Explanted for Unknown Reason
crt, lead explanted, icd explanted, ventricular lead, explanted replaced
1
reports
Oversensing Twos / Wave Oversensing / Use Right
oversensing twos, lead remains, wave oversensing, lead exhibited, use right
1
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
Early ICD lead failure in defibrillator systems with multiple leads via cephalic access
Chirag R. Barbhaiya, et al. · Journal of Cardiovascular Electrophysiology · 2020
Failure rates of single- versus dual-coil nonrecalled sprint quattro defibrillator leads.
Shariff N, et al. · The American journal of cardiology · 2014
Internal insulation breaches in an implantable cardioverter-defibrillator lead with redundant conductors.
Hauser RG, et al. · Heart rhythm · 2019
Class I recall of defibrillator leads: a comparison of the Sprint Fidelis and Riata families.
Liu J, et al. · Heart rhythm · 2012
Comparison of longevity and clinical outcomes of implantable cardioverter-defibrillator leads among manufacturers.
Kawada S, et al. · Heart rhythm · 2017
Citations indexed from PubMed.
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