MAUDE report
MAUDE report 8113: BIPOLAR ENDOCARDIAL LEAD
Malfunction · received Mar 23, 1994 · CARDIAC PACEMAKERS, INC.
Key facts
| MDR report key | 8113 |
|---|---|
| Report number | 8113 |
| Event type | Malfunction |
| Brand name | BIPOLAR ENDOCARDIAL LEAD |
| Model number | 4261-59CM |
| Manufacturer | CARDIAC PACEMAKERS, INC. |
| Product code | DTB |
| Device class | Class III |
| Date received by FDA | Mar 23, 1994 |
| Report date | Mar 23, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 100–999 MAUDE reports for this brand
- 1–9 Death reports for this brand
- 100–999 Injury reports for this brand
- No Adverse event flagged
- Yes 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: