MAUDE manufacturer profile

MEDTRONIC, INC. · DSI

MAUDE profile for Detector And Alarm, Arrhythmia

Key facts

Manufacturer MEDTRONIC, INC.
Manufacturer group MEDTRONIC, INC.
Product code DSI
Product code name Detector And Alarm, Arrhythmia

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Communication or Transmission Problem, Adverse Event Without Identified Device or Use Problem, Device Difficult to Program or Calibrate, Under-Sensing, Migration or Expulsion of Device, 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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