MAUDE manufacturer profile
BIOTRONIK SE & CO KG · NVZ
MAUDE profile for Pulse Generator, Permanent, Implantable
Key facts
| Manufacturer | BIOTRONIK SE & CO KG |
|---|---|
| Manufacturer group | BIOTRONIK SE & CO KG |
| Product code | NVZ |
| Product code name | Pulse Generator, Permanent, Implantable |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Unspecified Infection, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Premature Elective Replacement Indicator, Failure to Capture, Failure to Interrogate, Battery 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