MAUDE manufacturer profile
BIOTRONIK SE & CO. KG · DTB
MAUDE profile for Permanent Pacemaker Electrode
Key facts
| Manufacturer | BIOTRONIK SE & CO. KG |
|---|---|
| Manufacturer group | BIOTRONIK SE & CO. KG |
| Product code | DTB |
| Product code name | Permanent Pacemaker Electrode |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Unspecified Infection, Insufficient Information, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, High impedance, Failure to Capture 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