MAUDE manufacturer profile
ABBOTT · NKE
MAUDE profile for Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Key facts
| Manufacturer | ABBOTT |
|---|---|
| Manufacturer group | ABBOTT |
| Product code | NKE |
| Product code name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Over-Sensing, No Known Impact Or Consequence To Patient, Pacing Problem, Failure to Capture, Incorrect Measurement, Failure to Interrogate, Adverse Event Without Identified Device or Use 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