MAUDE brand profile

EMPRISE XL DR

MAUDE brand safety profile

Key facts

Brand name EMPRISE XL DR

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Premature Discharge of Battery, Incorrect Measurement, No Known Impact Or Consequence To Patient, Pacemaker Found in Back-Up Mode, Charging Problem, Over-Sensing, No Device Output Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE brand safety profiles

Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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