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Claria MRI Quad CRT-D SureScan Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · CRT-Defibrillator (CRT-D) · First cleared Apr 2017 · 2 device variants grouped

Total Reports

4,088

Reports (30d)

17

Active Signals

1

Open Recalls

78

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

CRT Explanted Due to Infection

resynchronization, crt, infection, patient complications, result event

9

reports

2

Inappropriate Therapy for Atrial Events

crt, therapy, complications, tachycardia, ventricular tachycardia

8

reports

3

Undersensing During Atrial Events

fibrillation, crt, atrial, lead, tachycardia

6

reports

4

Premature Battery Depletion Observed

defibrillator crt, cardiac resynchronization, battery, crt, resynchronization therapy

3

reports

5

Lead Integrity Alert for Oversensing

non sustained, crt, sustained, lead, use

2

reports

6

Inappropriate Shock Delivered by ICD

implantable cardioverter, icd, shock, cardioverter defibrillator, defibrillator icd

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

Increasing trendcritical

Regulatory

FDA recalls for this device

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.

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

Lewalter T, et al. · Pacing and clinical electrophysiology : PACE · 2007

Ventricular fibrillation count by noise oversensing in a cardiac resynchronization therapy‐defibrillator induced by side branch protection during percutaneous coronary intervention

Sho Tanabe, et al. · Journal of Arrhythmia · 2022

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.