FDA Adverse Event
Malfunction
Summary report: N
LUMAX 540 DR-T
MDR report key: 2024004
·
Received February 14, 2011
Report
- Report Number
- 1028232-2011-00297
- Event Type
- Malfunction
- Date Received
- February 14, 2011
- Date of Event
- February 3, 2011
- Report Date
- February 3, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- MRM
- PMA / PMN Number
- P000009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ON (B)(6) 2011, A HOME MONITORING ALERT WAS REC'D INDICATING THAT THIS DEVICE WAS IN THE EOS STATE. THE PT WAS ASKED TO REPORT TO THE DOCTOR'S OFFICE; SO THAT, AN INVESTIGATION OF THE ALERT COULD BE PERFORMED. AFTER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS IN THE EOS STATE, AND REPLACEMENT OF THE DEVICE WAS RECOMMENDED. ON (B)(6) 2011 - THIS DEVICE WAS EXPLANTED ON (B)(6) 2011 AND WAS REPLACED WITH A MEDTRONIC DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 540 DR-T | ICD | MRM | BIOTRONIK SE & CO. KG | 360346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization |