MAUDE manufacturer profile
MEDTRONIC PUERTO RICO OPERATIONS CO. · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
|---|---|
| Manufacturer group | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Product code | LWS |
| Product code name | Implantable Cardioverter Defibrillator (Non-Crt) |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Shock from Patient Lead(s), Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem, Adverse Event Without Identified Device or Use Problem, Unspecified Infection, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Pacing Problem 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