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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Cardiac Rhythm Management
MAUDE LookupCardiac Rhythm ManagementBioMonitor IIIm

BioMonitor IIIm Adverse Events: FDA MAUDE Data

BIOTRONIK SE & Co. KG · Insertable Cardiac Monitor (ICM/ILR) · First cleared Apr 2020

Total Reports

410

Reports (30d)

4

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Device Explanted Due to Noise

explanted, noise, battery, adverse, additional information

13

reports

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

Detection

Active safety signals

Disproportionate reportinghigh

Evidence

Related research

Implantable loop recorder migration: Case-based review and implications for clinical practice

Allam Harfoush · American Heart Journal Plus Cardiology Research and Practice · 2025

Ventricular Arrhythmia and Cardiac Fibrosis in Endurance Experienced Athletes (VENTOUX).

Javed W, et al. · 2025

Pre-deployment assessment of an AI model to assist radiologists in chest X-ray detection and identification of lead-less implanted electronic devices for pre-MRI safety screening: realized implementation needs and proposed operational solutions.

White RD, et al. · 2022

Effectiveness of a novel intervention (Super Rehab) in overweight patients with atrial fibrillation (SuRe AF): protocol for a randomised controlled trial.

Murphy D, et al. · 2025

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.

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How a safety signal is detected

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

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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.