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SUBCUTANEOUS, UNIPOLAR LEAD Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD)

Total Reports

176

Reports (30d)

3

Active Signals

0

Open Recalls

82

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

High Shock Impedance Measurements Observed

impedance measurements, measurements, shock impedance, ohms, range

2

reports

2

RA Lead Undersensing During Atrial Events

fibrillation, atrial, atrial fibrillation, tachycardia, detected

1

reports

3

Rising Defibrillation Impedance in RV Lead

lead remains, pacing impedance, impedance, lead exhibited, use right

1

reports

4

RV Lead Explanted for Unknown Reason

lead explanted, post, defibrillation, atrial lead, right atrial

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

Class II

Oct 29, 2025 · Open, Classified

There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Class II

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

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

Navigating Complications in Cardiac Pacemakers: A Comprehensive Review and Management Strategies

Anil Sriramoju, et al. · Reviews in Cardiovascular Medicine · 2024

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.