MAUDE manufacturer profile

MEDTRONIC NEUROMODULATION · DTB

MAUDE profile for Permanent Pacemaker Electrode

Key facts

Manufacturer MEDTRONIC NEUROMODULATION
Manufacturer group MEDTRONIC SINGAPORE OPERATIONS
Product code DTB
Product code name Permanent Pacemaker Electrode

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, High Capture Threshold, Over-Sensing, Adverse Event Without Identified Device or Use Problem, High impedance, Unspecified Infection, Signal Artifact/Noise, Failure to Capture 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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