MAUDE manufacturer profile

MEDTRONIC NAVIGATION, INC. · PGW

MAUDE profile for Ear, Nose, And Throat Stereotaxic Instrument

Key facts

Manufacturer MEDTRONIC NAVIGATION, INC.
Manufacturer group MEDTRONIC NAVIGATION, INC.
Product code PGW
Product code name Ear, Nose, And Throat Stereotaxic Instrument

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Application Program Freezes, Becomes Nonfunctional, Human-Device Interface Problem, Device Sensing Problem, Display or Visual Feedback Problem, Imprecision, Application Program Problem 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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