MAUDE manufacturer profile
PLEXUS MANUFACTURING SDN. BHD. · DTE
MAUDE profile for Pulse-Generator, Pacemaker, External
Key facts
| Manufacturer | PLEXUS MANUFACTURING SDN. BHD. |
|---|---|
| Manufacturer group | MEDTRONIC, INC. |
| Product code | DTE |
| Product code name | Pulse-Generator, Pacemaker, External |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, Connection Problem, No Known Impact Or Consequence To Patient, Mechanical Problem, No Display/Image, Device Displays Incorrect Message, Calibration Problem, Break 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