MAUDE manufacturer profile

ABBOTT · DTB

MAUDE profile for Permanent Pacemaker Electrode

Key facts

Manufacturer ABBOTT
Manufacturer group ABBOTT
Product code DTB
Product code name Permanent Pacemaker Electrode

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Over-Sensing, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Signal Artifact/Noise, Break, Device Dislodged or Dislocated, Failure to Capture, Low impedance 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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