MAUDE manufacturer profile

MEDTRONIC, INC. · OSR

MAUDE profile for Pacemaker/Icd/Crt Non-Implanted Components

Key facts

Manufacturer MEDTRONIC, INC.
Manufacturer group MEDTRONIC, INC.
Product code OSR
Product code name Pacemaker/Icd/Crt Non-Implanted Components

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, Computer Software Problem, Computer Operating System Problem, Communication or Transmission Problem, Output Problem, Data Problem, Display or Visual Feedback Problem, Inadequate User Interface 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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