FDA Adverse Event
Injury
Summary report: N
LINOX SD 65/18
MDR report key: 1080470
·
Received July 21, 2008
Report
- Report Number
- 1028232-2008-00745
- Event Type
- Injury
- Date Received
- July 21, 2008
- Date of Event
- June 14, 2008
- Report Date
- June 18, 2008
- Manufacturer
- BIOTRONIK GMBH & CO.
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS SYSTEM WAS REMOVED DUE TO INFECTION. THE INFECTED SYSTEM: LUMAX 340 DR-T, MDR: 1028232-2008-00744, LINOX SD 65/18, MDR: 1028232-2008-00745.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SD 65/18 | ICD LEAD | LWS | BIOTRONIK GMBH & CO. | 350054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization |