MAUDE manufacturer profile
ABBOTT · LWO
MAUDE profile for Pulse-Generator, Single Chamber, Sensor Driven, Implantable
Key facts
| Manufacturer | ABBOTT |
|---|---|
| Manufacturer group | ABBOTT |
| Product code | LWO |
| Product code name | Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Premature Discharge of Battery, No Pacing, Failure to Interrogate, Failure to Capture, No Known Impact Or Consequence To Patient, Interrogation Problem, Fatigue 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