MAUDE report
MAUDE report 33650: PRELUDE 3.2 MM IS-1 PROGRAMMABLE POLARITY PULSE GENERATOR
Injury · received May 15, 1996 · CARDIAC PACEMAKERS
Key facts
| MDR report key | 33650 |
|---|---|
| Report number | 2124215-1996-00041 |
| Event type | Injury |
| Brand name | PRELUDE 3.2 MM IS-1 PROGRAMMABLE POLARITY PULSE GENERATOR |
| Model number | 1226 |
| Manufacturer | CARDIAC PACEMAKERS |
| Product code | DXY |
| Device class | Class III |
| Date received by FDA | May 15, 1996 |
| Report date | May 15, 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
- 1–9 Death reports for this brand
- 10–99 Injury reports for this brand
- 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: