MAUDE manufacturer profile
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
| Product code | LWS |
| Product code name | Implantable Cardioverter Defibrillator (Non-Crt) |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Inappropriate or Unexpected Reset, Over-Sensing, Adverse Event Without Identified Device or Use Problem, Shock from Patient Lead(s), Inappropriate/Inadequate Shock/Stimulation, Fatigue, Death 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