MAUDE manufacturer profile
MEDTRONIC SOFAMOR DANEK USA, INC · GWF
MAUDE profile for Stimulator, Electrical, Evoked Response
Key facts
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
|---|---|
| Manufacturer group | MEDTRONIC SOFAMOR DANEK USA, INC |
| Product code | GWF |
| Product code name | Stimulator, Electrical, Evoked Response |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Use of Device Problem, No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Failure to Calibrate, No Patient Involvement, Failure to Sense, Device Sensing 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