FDA Adverse Event
Injury
Summary report: N
LINOX SD 65/16
MDR report key: 1012595
·
Received March 12, 2008
Report
- Report Number
- 1028232-2008-00239
- Event Type
- Injury
- Date Received
- March 12, 2008
- Date of Event
- February 7, 2008
- Report Date
- February 18, 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
- OTHER
Narratives
Description of Event or Problem · 1
PER OOS, THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SYSTEM WAS DISCARDED BY HOSPITAL. ALSO REMOVED: LUMAX 340 DR-T, MDR 1028232-2008-00235; SETROX S 45, MDR 1028232-2008-00236.
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 | 70 YR | Hospitalization |