FDA Adverse Event
Injury
Summary report: N
LUMAX 340 DR-T
MDR report key: 1260626
·
Received December 9, 2008
Report
- Report Number
- 1028232-2008-01612
- Event Type
- Injury
- Date Received
- December 9, 2008
- Date of Event
- November 5, 2008
- Report Date
- November 17, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- MRM
- PMA / PMN Number
- P000009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS SYSTEM WAS REMOVED DUE TO INFECTION. LUMAX 340 DR-T, MDR 1028232-2008-01612. SELOX JT 53, MDR 1028232-2008-01613. LINOX T 65, MDR 1028232-2008-01614.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 340 DR-T | ICD | MRM | BIOTRONIK GMBH AND CO. | 355267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization |