Lumax 740 VR-T DX Adverse Events: FDA MAUDE Data

BIOTRONIK SE & Co. KG · Implantable Cardioverter Defibrillator (ICD) · First cleared Jul 2013

Total Reports

196

Reports (30d)

3

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

Device Explanted for ERI Status

replacement, additional information, normal, showed, stable

2

reports

2

ICD Explanted for EOS Indication

currently, battery, additional information, device remains, remains implanted

2

reports

3

Unexpected Battery Behavior in Device

currently, battery, additional information, device remains, remains implanted

1

reports

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

Active safety signals

Disproportionate reportinghigh

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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.