MAUDE manufacturer profile
MDT PUERTO RICO OPERATIONS CO, MED REL · DXY
MAUDE profile for Implantable Pacemaker Pulse-Generator
Key facts
| Manufacturer | MDT PUERTO RICO OPERATIONS CO, MED REL |
|---|---|
| Manufacturer group | MDT PUERTO RICO OPERATIONS CO, MED REL |
| Product code | DXY |
| Product code name | Implantable Pacemaker Pulse-Generator |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Failure to Interrogate, Battery Problem, Appropriate Term/Code Not Available, Adverse Event Without Identified Device or Use Problem, Unspecified Infection, Premature Discharge of Battery, Data 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