MAUDE manufacturer profile
IMPULSE DYNAMICS USA, INC. · QFV
MAUDE profile for Implantable Pulse Generator
Key facts
| Manufacturer | IMPULSE DYNAMICS USA, INC. |
|---|---|
| Manufacturer group | IMPULSE DYNAMICS USA, INC. |
| Product code | QFV |
| Product code name | Implantable Pulse Generator |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Failure of Implant, Computer Software Problem, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Failure to Charge, Unspecified Infection, Heart Failure/Congestive Heart Failure, Prophylactic removal due to corrective action 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