MAUDE manufacturer profile
GUIDANT CRM CLONMEL IRELAND · NKE
MAUDE profile for Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Key facts
| Manufacturer | GUIDANT CRM CLONMEL IRELAND |
|---|---|
| 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
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Unspecified Infection, No Known Impact Or Consequence To Patient, High impedance, Ambient Noise Problem, No Consequences Or Impact To Patient, Over-Sensing, Pacing Problem 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