FDA Adverse Event
Other
Summary report: N
BELOS VR
MDR report key: 660786
·
Received January 6, 2006
Report
- Report Number
- 1028232-2005-00219
- Event Type
- Other
- Date Received
- January 6, 2006
- Report Date
- January 3, 2006
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PRODUCT RETURNED BY GUIDANT CORPORATION WITH NO OOS REPORT.
Description of Event or Problem · 1
PRODUCT RETURNED BY GUIDANT CORP WITH NO OOS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BELOS VR | ICD | LWS | BIOTRONIK GMBH AND CO. | 330444 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |