MAUDE manufacturer profile
BIOTRONIK SE & CO. KG · OJX
MAUDE profile for Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
Key facts
| Manufacturer | BIOTRONIK SE & CO. KG |
|---|---|
| Manufacturer group | BIOTRONIK SE & CO. KG |
| Product code | OJX |
| Product code name | Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
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, Device Dislodged or Dislocated, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Unspecified Infection, High impedance, Failure to Capture, High Capture Threshold 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