FDA Adverse Event
Injury
Summary report: N
LUMOS VR-T
MDR report key: 1001933
·
Received February 15, 2008
Report
- Report Number
- 1028232-2008-00187
- Event Type
- Injury
- Date Received
- February 15, 2008
- Report Date
- January 15, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO
- Product Code
- LWS
- PMA / PMN Number
- P000009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THIS DEVICE WAS RETURNED WITHOUT OOS DOCUMENTATION FROM AN UNK SOURCE. THE SHOCK TABLE INDICATES AN EXCESSIVE NUMBER OF CHARGES. THE DATE OF EXPLANT IS INK. THE FOLLOWING PHYSICIAN'S OFFICE WAS CONTACTED AND THE FOLLOWING INFO WAS PROVIDED. THE PT HAS EXPIRED BUT THE DATE OF DEATH WAS UNAVAILABLE. THE OFFICE HAD NO COMPLAINTS AGAINST THE OPERATION OF THE DEVICE. EXPLANT DATE IS UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMOS VR-T | ICD | LWS | BIOTRONIK GMBH AND CO | 353219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |