FDA Adverse Event
Injury
Summary report: N
VENTAK PRX MODEL 1705
MDR report key: 114716
·
Received August 6, 1997
Report
- Report Number
- 114716
- Event Type
- Injury
- Date Received
- August 6, 1997
- Date of Event
- December 28, 1996
- Report Date
- December 28, 1996
- Manufacturer
- C.P.I.
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
GENERATOR REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTAK PRX MODEL 1705 Implant | GENERATOR | LWS | C.P.I. | 1705 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R |