MAUDE manufacturer profile
BIOTRONIK SE & CO. KG · NVY
MAUDE profile for Permanent Defibrillator Electrodes
Key facts
| Manufacturer | BIOTRONIK SE & CO. KG |
|---|---|
| Manufacturer group | BIOTRONIK SE & CO KG |
| Product code | NVY |
| Product code name | Permanent Defibrillator Electrodes |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Over-Sensing, Ambient Noise Problem, Shock from Patient Lead(s), Inappropriate/Inadequate Shock/Stimulation, Adverse Event Without Identified Device or Use Problem, High impedance 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