FDA Adverse Event
Injury
Summary report: N
LUMOS VR-T
MDR report key: 820472
·
Received February 20, 2007
Report
- Report Number
- 1028232-2007-00027
- Event Type
- Injury
- Date Received
- February 20, 2007
- Date of Event
- September 25, 2006
- Report Date
- January 31, 2007
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- p000009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS ICD WAS EXPLANTED IN 2006, AFTER AN IMPLANTATION TIME OF 10 DAYS BECAUSE OF AN INFECTION. THE BIOTRONIK STERILIZATION PROTOCOL FROM AUGUST 2006 CONFIRMED THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., WERE IN THEIR SPECIFIED RANGES. ALSO, THE INVESTIGATION OF THE MICROBIOLOGICAL INDICATORS SHOWED THE SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS.
Description of Event or Problem · 1
THIS SYSTEM WAS REMOVED DUE TO INFECTION. ALSO INCLUDED WITH THIS SYSTEM IS A KENTROX SL 65/16, MDR 1028232-07-0028.
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 | 70 YR | Hospitalization |