MAUDE report
MAUDE report 58133: POLYSAFE ENDOCARDIAL PACING LEAD
Injury · received Dec 19, 1996 · CARDIAC CONTROL SYSTEMS, INC.
Key facts
| MDR report key | 58133 |
|---|---|
| Report number | 2522457-1996-00007 |
| Event type | Injury |
| Brand name | POLYSAFE ENDOCARDIAL PACING LEAD |
| Model number | AT-443 |
| Manufacturer | CARDIAC CONTROL SYSTEMS, INC. |
| Product code | DTB |
| Device class | Class III |
| Date received by FDA | Dec 19, 1996 |
| Report date | Nov 21, 1996 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 10–99 MAUDE reports for this brand
- None Death reports for this brand
- 10–99 Injury reports for this brand
- Yes Adverse event flagged
- No Product problem flagged
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE medical device reports
MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.
Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date: