FDA Adverse Event
Injury
Summary report: N
LINOX SD 65/16
MDR report key: 1101345
·
Received August 5, 2008
Report
- Report Number
- 1028232-2008-00838
- Event Type
- Injury
- Date Received
- August 5, 2008
- Date of Event
- June 25, 2008
- Report Date
- July 11, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER THE OOS, THIS SYSTEM WAS REMOVED DUE TO INFECTION. THIS SYSTEM WAS REPLACED WITH COMPETITOR'S DEVICES. EXPLANTED SYSTEM: LUMAX 340 HF-T, MDR: 1028232-2008-00836. COROX OTW 85-BP, MDR: 1028232-2008-00837. LINOX SD 64/16, MDR: 1028232-2008-00838. SETROX S 53, MDR: 1028232-2008-00839.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SD 65/16 | ICD LEAD | LWS | BIOTRONIK GMBH AND CO. | 350053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization |