MAUDE manufacturer profile
MEDTRONIC FABRICATION S.A.S. · DTB
MAUDE profile for Permanent Pacemaker Electrode
Key facts
| Manufacturer | MEDTRONIC FABRICATION S.A.S. |
|---|---|
| Manufacturer group | MEDTRONIC FABRICATION S.A.S. |
| Product code | DTB |
| Product code name | Permanent Pacemaker Electrode |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Over-Sensing, Appropriate Term/Code Not Available, Impedance Problem, Collapse, Signal Artifact/Noise, Under-Sensing 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