MAUDE manufacturer profile

MEDTRONIC MILACA, INC. · KRG

MAUDE profile for Programmer, Pacemaker

Key facts

Manufacturer MEDTRONIC MILACA, INC.
Manufacturer group MEDTRONIC MILACA, INC.
Product code KRG
Product code name Programmer, Pacemaker

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Communication or Transmission Problem, Device Difficult to Program or Calibrate, Output Problem, Computer Software Problem, Electrical /Electronic Property Problem, Under-Sensing 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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