MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Apr 2020
Total Reports
622
Reports (30d)
19
Active Signals
2
Open Recalls
82
What the reports describe · Claripulse analysis
ICD Withheld Therapy During VT Episode
patient complications, use, ventricular tachycardia, detected, result event
8
reports
ICD Explanted Due to Pocket Infection
infection, patient complications, pocket, icd explanted, result event
8
reports
Patient Reported Unwarranted Shock
icd remains, event patient, patient complications, use, result event
4
reports
ICD Delivered Inappropriate Therapy for AT/AF
fibrillation, atrial, atrial fibrillation, tachycardia, detected
2
reports
ICD Removed Due to Infection
infection, post, patient complications, patient experienced, result event
2
reports
ICD Delivered Inappropriate ATP for VT
anti tachycardia, tachycardia pacing, icd delivered, tachycardia, ventricular 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
Impact of magnetic fields from tablets, laptops, smartphones, and household/leisure magnets on cardiac implantable electronic devices.
Kamitani N, et al. · 2025
Citations indexed from PubMed.
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