FDA Adverse Event
Malfunction
Summary report: N
KRONOS LV-T
MDR report key: 1181892
·
Received September 25, 2008
Report
- Report Number
- 1028232-2008-01126
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- August 19, 2008
- Report Date
- August 26, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- MRM
- PMA / PMN Number
- P050023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS DEVICE WAS RETURNED WITH DOCUMENTATION FROM BIOTRONIK REP. THIS DEVICE WENT EOL IN 2 YEARS. THIS DEVICE WAS REPLACED WITH A LUMAX 340 HF-T.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KRONOS LV-T | CRT-D | MRM | BIOTRONIK GMBH AND CO. | 347406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization |