MAUDE manufacturer profile
NEUROPACE, INC. · PFN
MAUDE profile for Implanted Brain Stimulator For Epilepsy
Key facts
| Manufacturer | NEUROPACE, INC. |
|---|---|
| Manufacturer group | NEUROPACE, INC. |
| Product code | PFN |
| Product code name | Implanted Brain Stimulator For Epilepsy |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Bacterial Infection, Unspecified Infection, No Clinical Signs, Symptoms or Conditions, Signal Artifact/Noise, Wound Dehiscence, No Consequences Or Impact To Patient, Erosion 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