FDA Adverse Event
Injury
Summary report: N
LUMAX 340 VR-T
MDR report key: 1092663
·
Received August 1, 2008
Report
- Report Number
- 1028232-2008-00812
- Event Type
- Injury
- Date Received
- August 1, 2008
- Date of Event
- April 18, 2008
- Report Date
- July 1, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER OOS FROM REP, THIS SYSTEM WAS REMOVED DUE TO INFECTION. SYSTEM REMOVED: LUMAX 340 VR-T, MDR 1028232-2008-0812. LINOX SD 65/16, MDR 1028232-2008-00813.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 340 VR-T | ICD | LWS | BIOTRONIK GMBH AND CO | 355271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization |