MAUDE manufacturer profile
MICROPORT CRM S.R.L. · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | MICROPORT CRM S.R.L. |
|---|---|
| Manufacturer group | MICROPORT CRM S.R.L. |
| Product code | LWS |
| Product code name | Implantable Cardioverter Defibrillator (Non-Crt) |
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, Inappropriate/Inadequate Shock/Stimulation, Premature Discharge of Battery, Data Problem, Display or Visual Feedback Problem, Insufficient Information, Shock from Patient Lead(s) 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