MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · NKE
MAUDE profile for Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | NKE |
| Product code name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
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, Incorrect, Inadequate or Imprecise Result or Readings, Premature Discharge of Battery, Over-Sensing, Adverse Event Without Identified Device or Use Problem, Pacing Problem, Unspecified Infection, High impedance 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