FDA Adverse Event
Other
Summary report: N
LUMAX 540 VR-T
MDR report key: 2132466
·
Received June 13, 2011
Report
- Report Number
- 1028232-2011-01287
- Event Type
- Other
- Date Received
- June 13, 2011
- Date of Event
- January 12, 2010
- Report Date
- May 25, 2011
- Manufacturer
- BIOTRONIK SE &CO. KG
- Product Code
- MRM
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THIS DEVICE WAS RETURNED WITHOUT DOCUMENTATION FROM AN UNK SOURCE. THE FOLLOWING PHYSICIAN'S OFFICE HAS NOT SEEN THIS PT SINCE 2009, WHEN THE PT SWITCHED FOLLOWING PHYSICIANS. MEDTRONIC, BOSTON SCIENTIFIC, ST JUDE MEDICAL AND ELA HAVE NO RECORD OF THIS PT. PER THE IMPLANTING PHYSICIAN'S OFFICE, THIS DEVICE WAS REPLACED ON (B)(6) 2010 WITH A ST JUDE DEVICE. ST JUDE HAS NO RECORD OF THIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 540 VR-T | ICD | MRM | BIOTRONIK SE &CO. KG | 360348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization |