MAUDE manufacturer profile
ST. JUDE MEDICAL, INC. (CRM-KISTA) · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | ST. JUDE MEDICAL, INC. (CRM-KISTA) |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL, INC. (CRM-KISTA) |
| Product code | LWS |
| Product code name | Implantable Cardioverter Defibrillator (Non-Crt) |
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
- No Known Impact Or Consequence To Patient, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Premature Discharge of Battery, Shock from Patient Lead(s), Inappropriate or Unexpected Reset, Device Operates Differently Than Expected, 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