MAUDE manufacturer profile

MEDTRONIC, INC. · QZI

MAUDE profile for Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Key facts

Manufacturer MEDTRONIC, INC.
Manufacturer group MEDTRONIC, INC.
Product code QZI
Product code name Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Use of Device Problem, Tachycardia, Heart Block, Pericardial Effusion, Ventricular Fibrillation, Low Blood Pressure/ Hypotension 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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