MAUDE manufacturer profile

MEDTRONIC HEART VALVES DIVISION · LWR

MAUDE profile for Heart-Valve, Non-Allograft Tissue

Key facts

Manufacturer MEDTRONIC HEART VALVES DIVISION
Manufacturer group MEDTRONIC HEART VALVES DIVISION
Product code LWR
Product code name Heart-Valve, Non-Allograft Tissue

At a glance

  • 1,000+ MAUDE reports
  • 100–999 Death reports
  • 1,000+ Injury reports
  • 100–999 Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • Insufficient Information, Aortic Valve Stenosis, No Information, Aortic Valve Insufficiency/ Regurgitation, Adverse Event Without Identified Device or Use Problem, Gradient Increase, Intravalvular regurgitation Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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