FDA Adverse Event
Injury
Summary report: N
LUMAX 340 HF-T
MDR report key: 2212971
·
Received August 5, 2011
Report
- Report Number
- 1028232-2011-01750
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- June 8, 2011
- Report Date
- July 26, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- MRM
- PMA / PMN Number
- P050023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
WE WERE INFORMED THAT THIS PT REPORTED TO THE ER WITH CELLULITIS OF THE ICD AREA. ANTIBIOTICS WERE ADMINISTERED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 340 HF-T | CRT-D | MRM | BIOTRONIK SE & CO. KG | 355263 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization |