SPRINT FIDELIS Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD)
Total Reports
4,657
Reports (30d)
18
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
24
reports
Integrity / Lia / Alert Lia
integrity alert, lead integrity, alert lia, lia, integrity
13
reports
Fracture / Ventricular Lead / Lead Explanted
lead explanted, fracture, voltage, explanted replaced, ventricular lead
6
reports
Atrial Lead Exhibited High Thresholds
atrial, lead exhibited, remain use, atrial lead, use right
3
reports
ICD System Explanted for Unknown Reason
crt, lead explanted, icd explanted, ventricular lead, explanted replaced
2
reports
Post / Ventricular Lead / Thresholds
atrial, lead explanted, post, thresholds, ventricular lead
1
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
Characteristics of Sprint Fidelis lead failure.
Beukema RJ, et al. · Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2010
Comparison of lead failure manifestation of Biotronik Linox with St. Jude Medical Riata and Medtronic Sprint Fidelis lead.
Lam A, et al. · Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2018
Passive-fixation lead failure rates and long-term patient mortality in subjects implanted with Sprint Fidelis electrodes.
Vollmann D, 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
Management of functional Sprint Fidelis leads at cardiac resynchronization therapy-defibrillator generator replacement: a novel option for preventing inappropriate shocks from lead failure in fragile patients with high risk of sudden death.
Zhu DWX, 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 · 2017
The Medtronic Sprint Fidelis® lead history revisited-Extended follow-up of passive leads.
Frey SM, et al. · Pacing and clinical electrophysiology : PACE · 2019
Citations indexed from PubMed.
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