FDA Adverse Event
Other
Summary report: N
LIVIAN RF HE - IS-1/DF-1/IS-1
MDR report key: 1383549
·
Received February 10, 2009
Report
- Report Number
- 2124215-2008-02978
- Event Type
- Other
- Date Received
- February 10, 2009
- Date of Event
- December 8, 2008
- Report Date
- February 10, 2009
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NIK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIVIAN RF HE - IS-1/DF-1/IS-1 | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT PUERTO RICO BV | H227 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |