MAUDE brand profile

PROTECTA XT VR

MAUDE brand safety profile

Key facts

Brand name PROTECTA XT VR

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 100–999 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Premature Discharge of Battery, No Clinical Signs, Symptoms or Conditions, Shock from Patient Lead(s), Inappropriate/Inadequate Shock/Stimulation, Adverse Event Without Identified Device or Use Problem, Over-Sensing, Device Sensing Problem 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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