MAUDE manufacturer profile
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) · NKE
MAUDE profile for Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Key facts
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Product code | NKE |
| Product code name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Unspecified Infection, Death, Over-Sensing, Pacemaker Found in Back-Up Mode, Device Operates Differently Than Expected, Premature Discharge of Battery 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