MAUDE manufacturer profile
MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA |
|---|---|
| Manufacturer group | MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA |
| Product code | LWS |
| Product code name | Implantable Cardioverter Defibrillator (Non-Crt) |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Fracture, High impedance, No Clinical Signs, Symptoms or Conditions, Over-Sensing, Signal Artifact/Noise, Impedance Problem, Low impedance 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