MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Jan 2016
Total Reports
1,116
Reports (30d)
7
Active Signals
1
Open Recalls
82
What the reports describe · Claripulse analysis
RV Lead Exhibited High Thresholds
lead remains, lead exhibited, thresholds, exhibited high, use right
5
reports
RV Lead Triggered Low Pacing Impedance Alert
lead remains, pacing impedance, alert, use right, lead triggered
2
reports
RV Lead Exhibited T-Wave Oversensing Post Sensing
oversensing twos, wave oversensing, lead exhibited, use right, twos
2
reports
RV Lead Exhibited High Pacing Impedance
lead remains, pacing impedance, impedance, lead exhibited, use right
1
reports
CRT-D Explanted Due to Infection
cardiac resynchronization, crt, infection, therapy defibrillator, resynchronization therapy
1
reports
RV Lead Oversensing Causing Pacing Inhibition
patient complications, alert lia, result event, lia, integrity
1
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
Failure rates of single- versus dual-coil nonrecalled sprint quattro defibrillator leads.
Shariff N, et al. · 2014
Failure-free survival of the Durata defibrillator lead.
Liu J, et al. · 2013
Early ICD lead failure in defibrillator systems with multiple leads via cephalic access
Chirag R. Barbhaiya, et al. · Journal of Cardiovascular Electrophysiology · 2020
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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