MAUDE manufacturer profile
GREATBATCH MEDICAL · DTB
MAUDE profile for Permanent Pacemaker Electrode
Key facts
| Manufacturer | GREATBATCH MEDICAL |
|---|---|
| Manufacturer group | GREATBATCH MEDICAL |
| Product code | DTB |
| Product code name | Permanent Pacemaker Electrode |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Unspecified Infection, Therapeutic Response, Decreased, No Clinical Signs, Symptoms or Conditions, Failure to Capture, High Capture Threshold, Bacterial Infection, Insufficient Information 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