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Crome DR MRI SureScan Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Apr 2020 · 2 device variants grouped

Total Reports

213

Reports (30d)

6

Active Signals

2

Open Recalls

82

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

ICD Replaced for Premature Battery Depletion

icd remains, battery, icd exhibited, icd explanted, explanted replaced

4

reports

2

Inappropriate ATP and Shock Delivered

svt, tachycardia svt, tachycardia, ventricular tachycardia, detected

4

reports

3

Set Screw Problem During Implant

atrial, replacement, remain use, inappropriate shock, ventricular lead

2

reports

4

High-Voltage Therapy Not Delivered

triggered, high voltage, programmed, voltage, delivered

1

reports

5

Impedance / Ventricular Lead / Pacing Impedance

lead remains, pacing impedance, impedance, high, ventricular lead

1

reports

6

ICD System Explanted for Unknown Reason

crt, lead explanted, icd explanted, ventricular lead, explanted replaced

1

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

ChangepointhighDisproportionate reportingmedium

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

Mitacchione G, et al. · Journal of cardiovascular electrophysiology · 2020

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.