MAUDE manufacturer profile
MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) · OWB
MAUDE profile for Interventional Fluoroscopic X-Ray System
Key facts
| Manufacturer | MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) |
|---|---|
| Manufacturer group | MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) |
| Product code | OWB |
| Product code name | Interventional Fluoroscopic X-Ray System |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Failure to Advance, Application Program Freezes, Becomes Nonfunctional, Incorrect, Inadequate or Imprecise Result or Readings, Radiation Output Failure, Display or Visual Feedback Problem, Application Program Problem, Mechanical Problem 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