MAUDE manufacturer profile

MEDTRONIC, INC. · DTE

MAUDE profile for Pulse-Generator, Pacemaker, External

Key facts

Manufacturer MEDTRONIC, INC.
Manufacturer group MEDTRONIC, INC.
Product code DTE
Product code name Pulse-Generator, Pacemaker, External

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 Clinical Signs, Symptoms or Conditions, Connection Problem, No Display/Image, Mechanical Problem, Calibration Problem, Display or Visual Feedback Problem, Output Problem, Device Sensing 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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