MAUDE manufacturer profile

MEDTRONIC PUERTO RICO OPERATIONS CO. · MBX

MAUDE profile for Stimulator, Thalamic, Epilepsy, Implanted

Key facts

Manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer group MEDTRONIC PUERTO RICO OPERATIONS CO.
Product code MBX
Product code name Stimulator, Thalamic, Epilepsy, Implanted

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, High impedance, Convulsion/Seizure, Battery Problem, Insufficient Information, Failure to Deliver Energy 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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