SPRINT FIDELIS Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD)
Total Reports
4,653
Reports (30d)
48
Active Signals
1
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
28
reports
RV Lead Integrity Alert Triggered
integrity alert, lead integrity, alert lia, lia, integrity
8
reports
Suspected Lead Fracture in RV Lead
suspected, lead explanted, fracture, voltage, low
7
reports
RV Lead Capped Due to Performance Issue
lead explanted, lead exhibited, use right, analyzed
3
reports
T-Wave Oversensing in RV Lead
oversensing twos, wave oversensing, lead exhibited, use right, twos
3
reports
RV Lead Undersensing Observed
episode, lead remains, undersensing, lead exhibited, use right
2
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
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
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
Class I recall of defibrillator leads: a comparison of the Sprint Fidelis and Riata families.
Liu J, et al. · Heart rhythm · 2012
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
Citations indexed from PubMed.
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