MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Dec 2014
Total Reports
258
Reports (30d)
1
Active Signals
1
Open Recalls
82
What the reports describe · Claripulse analysis
ICD Explanted for Premature Battery Depletion
depletion, battery, icd exhibited, explanted replaced, battery depletion
2
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
Potential effects of low-dose average CT on cardiac implantable electronic devices.
Pan EY, et al. · 2018
Wideband radiofrequency pulse sequence for evaluation of myocardial scar in patients with cardiac implantable devices
Neil Shah, et al. · Frontiers in Radiology · 2024
Orthostatic increase in defibrillation threshold leading to defibrillation failure and prolonged cardiac arrest in a sitting position: Lessons from a patient's near-fatal experience.
Liu X, et al. · 2016
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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