FDA Adverse Event
Injury
Summary report: N
LUMOS DR-T
MDR report key: 2982187
·
Received January 31, 2007
Report
- Report Number
- 1028232-2007-00004
- Event Type
- Injury
- Date Received
- January 31, 2007
- Date of Event
- January 5, 2007
- Report Date
- January 15, 2007
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS SYSTEM WAS EXPLANTED BECAUSE OF INFECTION AND POCKET EROSION. IT WAS UNK WHAT DATE THIS WAS REMOVED. ALSO INCLUDED WITH THIS SYSTEM ARE: SELOX JT 45, SN: (B)(4), MDR 1028232-2007-0006, KENTROX SL 65/16, SN: (B)(4), MDR 1028232-2007-0005.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMOS DR-T | ICD | LWS | BIOTRONIK GMBH AND CO. | 353220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization |