MAUDE manufacturer profile
CPI - DEL CARIBE · NIK
MAUDE profile for Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Key facts
| Manufacturer | CPI - DEL CARIBE |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | NIK |
| Product code name | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
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, High impedance, Failure to Capture, Adverse Event Without Identified Device or Use Problem, Unspecified Infection, No Known Impact Or Consequence To Patient, Capturing Problem, Fracture 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