MAUDE manufacturer profile
MEDTRONIC PUERTO RICO, INC. · DTB
MAUDE profile for Permanent Pacemaker Electrode
Key facts
| Manufacturer | MEDTRONIC PUERTO RICO, INC. |
|---|---|
| Manufacturer group | MPRI |
| Product code | DTB |
| Product code name | Permanent Pacemaker Electrode |
At a glance
- 1,000+ MAUDE reports
- 1,000+ 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, Signal Artifact/Noise, Fracture, Adverse Event Without Identified Device or Use Problem, High Capture Threshold, Over-Sensing, High impedance, 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