FDA Adverse Event
Injury
Summary report: N
LUMAX 540 HF-T
MDR report key: 1972239
·
Received January 21, 2011
Report
- Report Number
- 1028232-2011-00087
- Event Type
- Injury
- Date Received
- January 21, 2011
- Date of Event
- January 11, 2011
- Report Date
- January 13, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NIK
- PMA / PMN Number
- P050023
- 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 VEGETATION ON THE LEADS AND NOT REPLACED. THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 540 HF-T | CRT-D | NIK | BIOTRONIK SE & CO. KG | 360347 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization |