FDA Adverse Event
Malfunction
Summary report: N
LUMOS DR-T
MDR report key: 984402
·
Received January 18, 2008
Report
- Report Number
- 1028232-2007-00554
- Event Type
- Malfunction
- Date Received
- January 18, 2008
- Manufacturer
- BIOTRONIK, GMBH AND CO.
- Product Code
- MRM
- PMA / PMN Number
- P000009
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THIS DEVICE REACHED ERI IN 2007 ACCORDING TO HOME MONITORING REPORTS. ON THE FOLLOWING MONTH, THE DEVICE WAS INTERROGATED AND FOUND TO HAVE A VERY LOW BATTERY VOLTAGE OF APPROXIMATELY 4.5V. EXPLANT AND REPLACEMENT WAS RECOMMENDED AND CARRIED OUT ON THE NEXT DAY. DEVICE WAS RECEIVED ON 01/02/2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMOS DR-T | ICD | MRM | BIOTRONIK, GMBH AND CO. | 353220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |