FDA Adverse Event
Injury
Summary report: N
LUMAX 340 DR-T
MDR report key: 1201559
·
Received October 16, 2008
Report
- Report Number
- 1028232-2008-01271
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- September 2, 2008
- Report Date
- September 16, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO
- Product Code
- LWS
- PMA / PMN Number
- P000009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER OOS, THIS SYSTEM WAS REMOVED DUE TO INFECTION: LUMAX 340 DR-T, MDR 1028232-2008-01271. LINOX SD 65/16, MDR 1028232-2008-01272.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 340 DR-T | ICD | LWS | BIOTRONIK GMBH AND CO | 355267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization |