MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Oct 2023
Total Reports
499
Reports (30d)
24
Active Signals
1
Open Recalls
82
What the reports describe · Claripulse analysis
ICD Explanted Due to Pocket Infection
infection, patient complications, pocket, icd explanted, result event
16
reports
Poor Sensing During Defibrillation Testing
shock, defibrillation, testing, threshold, use
11
reports
ICD Delivered Inappropriate ATP for SVT
tachycardia, ventricular tachycardia, pacing atp, anti tachycardia, atp
2
reports
Patient Deceased Post ICD Implant
additional information, shock, post, provided, shocks
2
reports
ICD Exhibited Electromagnetic Interference
integrity alert, atrial, use, alert lia, lia
2
reports
ICD Delivered Inappropriate ATP for AF
anti tachycardia, atp, tachycardia pacing, fibrillation, tachycardia
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
Initial Experience of the Medtronic Aurora Extravascular Implantable Cardioverter in Children in a UK Centre
Georgia Spentzou, et al. · Pediatric Cardiology · 2025
Concomitant use of the novel extravascular implantable cardioverter-defibrillator with an epicardial pacemaker.
Graup V, et al. · 2025
Extravascular implantable cardioverter-defibrillator implantation in a teenager with Brugada syndrome and recurrent inappropriate shocks of subcutaneous implantable cardioverter-defibrillator.
Garibaldi S, et al. · 2025
Simultaneous use of extravascular implantable cardioverter-defibrillator and left ventricular pacing through the coronary sinus in a patient with a history of transcatheter edge-to-edge tricuspid valve repair
Marcin Michalak, et al. · Kardiologia Polska · 2025
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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