MAUDE manufacturer profile
ABBOTT · DXY
MAUDE profile for Implantable Pacemaker Pulse-Generator
Key facts
| Manufacturer | ABBOTT |
|---|---|
| Manufacturer group | ABBOTT |
| Product code | DXY |
| Product code name | Implantable Pacemaker Pulse-Generator |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Failure to Interrogate, Over-Sensing, Premature Discharge of Battery, No Pacing, Pacemaker Found in Back-Up Mode 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