FDA Adverse Event
Injury
Summary report: N
LUMAX 540 DR-T
MDR report key: 1991587
·
Received February 7, 2011
Report
- Report Number
- 1028232-2011-00256
- Event Type
- Injury
- Date Received
- February 7, 2011
- Date of Event
- November 11, 2010
- Report Date
- January 26, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- MRM
- PMA / PMN Number
- P000009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.
Description of Event or Problem · 1
THIS SYSTEM WAS EXPLANTED DUE TO LATENT POCKET INFECTION SECONDARY TO LEG ULCER INFECTION. THE SYSTEM REMAINS AT THE HOSPITAL AND HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 540 DR-T | CRT-D | MRM | BIOTRONIK SE & CO. KG | 360346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization |