FDA Adverse Event
Injury
Summary report: N
LUMAX 340 HF-T
MDR report key: 1101347
·
Received August 5, 2008
Report
- Report Number
- 1028232-2008-00836
- 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
- MRM
- PMA / PMN Number
- P050023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS DEVICE WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REP ELENA PAPPAS. 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 65/16, MDR: 1028232-2008-00838. SETROX S 53, MDR: 1028232-2008-00839.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 340 HF-T | CRT-D | MRM | BIOTRONIK GMBH AND CO. | 355263 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization |