MAUDE manufacturer profile
MEDTRONIC MED REL MEDTRONIC PUERTO RICO · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
|---|---|
| Manufacturer group | MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
| 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
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Shock from Patient Lead(s), Premature Discharge of Battery, Inappropriate/Inadequate Shock/Stimulation, Adverse Event Without Identified Device or Use Problem, Invalid Sensing, No Clinical Signs, Symptoms or Conditions, Battery 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