MAUDE manufacturer profile
CPI - DEL CARIBE · OJX
MAUDE profile for Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
Key facts
| Manufacturer | CPI - DEL CARIBE |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| 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
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Device Dislodged or Dislocated, Failure to Capture, High impedance, Adverse Event Without Identified Device or Use Problem, Unspecified Infection, Fracture, Pocket Stimulation 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