MAUDE manufacturer profile
MDT SOFAMOR DANEK PUERTO RICO MFG · NVZ
MAUDE profile for Pulse Generator, Permanent, Implantable
Key facts
| Manufacturer | MDT SOFAMOR DANEK PUERTO RICO MFG |
|---|---|
| Manufacturer group | MDT SOFAMOR DANEK PUERTO RICO MFG |
| Product code | NVZ |
| Product code name | Pulse Generator, Permanent, Implantable |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available, Failure to Interrogate, Pacing Problem, Unspecified Infection, Battery Problem, No Consequences Or Impact To Patient 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