MAUDE manufacturer profile

ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) · LWR

MAUDE profile for Heart-Valve, Non-Allograft Tissue

Key facts

Manufacturer ST. JUDE MEDICAL, INC. (CS-WOODRIDGE)
Manufacturer group ST. JUDE MEDICAL, INC. (CS-WOODRIDGE)
Product code LWR
Product code name Heart-Valve, Non-Allograft Tissue

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Aortic Regurgitation, Death, Aortic Valve Stenosis, Obstruction of Flow, Adverse Event Without Identified Device or Use Problem, Aortic Insufficiency, Insufficient Information, Endocarditis 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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