MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · NIK
MAUDE profile for Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| 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
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Unspecified Infection, High impedance, Over-Sensing, Pacing Problem, Signal Artifact/Noise, Inappropriate/Inadequate Shock/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