MAUDE manufacturer profile
BIOTRONIK SE & CO. KG · NKE
MAUDE profile for Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Key facts
| Manufacturer | BIOTRONIK SE & CO. KG |
|---|---|
| Manufacturer group | BIOTRONIK SE & CO. KG |
| Product code | NKE |
| Product code name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
At a glance
- 100–999 MAUDE reports
- 10–99 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, Unspecified Infection, No Clinical Signs, Symptoms or Conditions, Premature Elective Replacement Indicator, No Known Impact Or Consequence To Patient, Pocket Erosion, Hematoma, Insufficient Information 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