MAUDE manufacturer profile
MEDTRONIC EUROPE SARL · PNJ
MAUDE profile for Leadless Pacemaker
Key facts
| Manufacturer | MEDTRONIC EUROPE SARL |
|---|---|
| Manufacturer group | MEDTRONIC EUROPE SARL |
| Product code | PNJ |
| Product code name | Leadless Pacemaker |
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, Adverse Event Without Identified Device or Use Problem, Pericardial Effusion, No Clinical Signs, Symptoms or Conditions, Cardiac Arrest, Death, Premature Discharge of Battery, High Capture Threshold 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