MAUDE manufacturer profile
ST. JUDE MEDICAL, INC. (CRM-KISTA) · NIK
MAUDE profile for Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Key facts
| Manufacturer | ST. JUDE MEDICAL, INC. (CRM-KISTA) |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL, INC. (CRM-KISTA) |
| Product code | NIK |
| Product code name | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Over-Sensing, Premature Discharge of Battery, Adverse Event Without Identified Device or Use Problem, Device Operates Differently Than Expected, Inappropriate/Inadequate Shock/Stimulation, Shock from Patient Lead(s), Failure to Interrogate 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