SUBCUTANEOUS, UNIPOLAR LEAD Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD)
Total Reports
178
Reports (30d)
2
Active Signals
0
Open Recalls
82
What the reports describe · Claripulse analysis
Most commonly reported problems
High Shock Impedance Measurements
measurements, high range, shock impedance, ohms, range
1
reports
Impedance / Ventricular Lead / Pacing Impedance
lead remains, pacing impedance, impedance, high, ventricular lead
1
reports
Inappropriate ATP During Atrial Events
fibrillation, atrial, atrial fibrillation, tachycardia, detected
1
reports
Integrity / Lia / Alert Lia
integrity alert, lead integrity, alert lia, lia, integrity
1
reports
Post / Ventricular Lead / Thresholds
atrial, lead explanted, post, thresholds, ventricular lead
1
reports
Ventricular Lead / Lead Explanted / Explanted Replaced
lead explanted, leads, right atrial, explanted replaced, ventricular lead
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
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
Related research
Context-dependent interactions between variable-loop pulsed field ablation and cardiac implantable electronic devices: a controlled preclinical study
Masateru Takigawa, et al. · European Heart Journal Open · 2026
Iatrogenic cardiac perforation due to pacemaker and defibrillator leads: a contemporary multicentre experience
Peter Henry Waddingham, et al. · EP Europace · 2022
Cardiac Implantable Electronic Miniaturized and Micro Devices
Moshe Rav-Acha, et al. · Micromachines · 2020
Subcutaneous implantable cardioverter-defibrillator implantation following left bundle branch area pacing: Navigating crosstalk
Piotr Hamala, et al. · Kardiologia Polska · 2026
Inappropriate shocks due to air entrapment in patients with subcutaneous implantable cardioverter‐defibrillator: A meta‐summary of case reports
Michele Iavarone, et al. · Pacing and Clinical Electrophysiology · 2022
Citations indexed from PubMed.
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