MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD)
Total Reports
4,507
Reports (30d)
32
Active Signals
1
Open Recalls
82
What the reports describe · Claripulse analysis
RV Lead Triggered Lead Integrity Alert
integrity alert, lead integrity, alert lia, lia, integrity
15
reports
RV Lead Suspected Fracture and Explanted
lead explanted, fracture, voltage, low, explanted replaced
7
reports
RV Lead Exhibited High Defibrillation Impedance
lead explanted, lead remains, impedance, lead exhibited, defibrillation
4
reports
RV Lead Exhibited High Pacing Impedance and Replaced
suspected, lead explanted, pacing impedance, lead exhibited, fracture
3
reports
RV Lead Exhibited High Thresholds
lead remains, lead exhibited, thresholds, exhibited high, use right
3
reports
RV Lead Triggered High Defibrillation Impedance Alert
triggered, impedance, coil, defibrillation, use
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
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
Outcomes of Sprint Fidelis and Riata lead extraction: Data from 2 high-volume centers.
El-Chami MF, et al. · 2015
Comparative outcomes of transvenous extraction of sprint fidelis and riata defibrillator leads: a single center experience.
Richardson TD, et al. · 2013
Class I recall of defibrillator leads: a comparison of the Sprint Fidelis and Riata families.
Liu J, et al. · 2012
Comparison of Sprint Fidelis and Riata defibrillator lead failure rates.
Fazal IA, et al. · 2012
Characteristics of Sprint Fidelis lead failure.
Beukema RJ, et al. · 2010
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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