FDA Adverse Event
Injury
Summary report: N
LUMAX 340 VR-T
MDR report key: 1211785
·
Received October 24, 2008
Report
- Report Number
- 1028232-2008-01300
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- November 15, 2007
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(SEE SCANNED PAGE).
Description of Event or Problem · 1
PER STUDY ADVERSE EVENT FORM, THIS PATIENT WAS GIVEN ANTIBIOTICS FOR AN INFECTION. THE SYSTEM WAS NOT REMOVED. SYSTEM BEING REPORTED: LUMAX 340 VR-T, MDR 1028232-2008-01300. LINOX SD 65/18, MDR 1028232-2008-01301.
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 | Required Intervention |