MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Nov 2022
Total Reports
619
Reports (30d)
2
Active Signals
1
Open Recalls
82
What the reports describe · Claripulse analysis
RV Lead Triggered Lead Integrity Alert
integrity alert, lead integrity, ventricular tachycardia, alert lia, lia
3
reports
ICD Exhibited Premature Battery Depletion
icd remains, use, icd exhibited, device remains, battery depletion
1
reports
ICD Experienced Loss of Telemetry
icd remains, use, icd exhibited, reported implantable, device remains
1
reports
ICD Experienced Premature Battery Depletion
depletion, battery, icd explanted, explanted replaced, battery depletion
1
reports
ICD Delivered Inappropriate ATP for SVT
tachycardia, ventricular tachycardia, pacing atp, anti tachycardia, atp
1
reports
ICD Withheld Therapy During VT Episode
patient complications, use, ventricular tachycardia, detected, result event
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
An unusual cause for inappropriate defibrillator shock.
Bera D, et al. · 2022
Rise in ICD pacing impedance: What is the cause?
Rangaswamy VV, et al. · 2022
Effects of Irradiation During Computed Tomography Scanning on the Function of Implantable Cardioverter-defibrillators.
Nishikawa Y, et al. · 2024
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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