MAUDE report
MAUDE report 54965: MEDTRONIC BIPOLAR HIGH EFFICIENCY LEAD
Malfunction · received Nov 27, 1996 · MEDTRONIC MIDWEST REGION
Key facts
| MDR report key | 54965 |
|---|---|
| Report number | 54965 |
| Event type | Malfunction |
| Brand name | MEDTRONIC BIPOLAR HIGH EFFICIENCY LEAD |
| Model number | 5034-58 |
| Catalog number | * |
| Manufacturer | MEDTRONIC MIDWEST REGION |
| Product code | DTB |
| Device class | Class III |
| Date received by FDA | Nov 27, 1996 |
| Report date | Nov 27, 1996 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 1–9 MAUDE reports for this brand
- None Death reports for this brand
- None 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: