MAUDE manufacturer profile
MANUFACTURED FOR MICROPORT CRM S.R.L. · DTB
MAUDE profile for Permanent Pacemaker Electrode
Key facts
| Manufacturer | MANUFACTURED FOR MICROPORT CRM S.R.L. |
|---|---|
| Manufacturer group | MANUFACTURED FOR MICROPORT CRM S.R.L. |
| Product code | DTB |
| Product code name | Permanent Pacemaker Electrode |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Wireless Communication Problem, No Information, Communication or Transmission Problem, Bradycardia, Failure to Power Up, Device Sensing Problem, High impedance 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