MAUDE manufacturer profile

MEDTRONIC NAVIGATION, INC. (LOUISVILLE) · HAW

MAUDE profile for Neurological Stereotaxic Instrument

Key facts

Manufacturer MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
Manufacturer group MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
Product code HAW
Product code name Neurological Stereotaxic Instrument

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Consequences Or Impact To Patient, No Patient Involvement, Device Operates Differently Than Expected, Imprecision, No Known Impact Or Consequence To Patient, Application Interface Becomes Non-Functional Or Program Exits Abnormally, Communication or Transmission Problem, Device Stops Intermittently 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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