FDA Adverse Event
Other
Summary report: N
KENTROX SL-S 65/16
MDR report key: 739455
·
Received July 21, 2006
Report
- Report Number
- 1028232-2006-00121
- Event Type
- Other
- Date Received
- July 21, 2006
- Report Date
- June 16, 2006
- Manufacturer
- BIOTRONIK GMBH AND CO
- Product Code
- LWS
- PMA / PMN Number
- p980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE BIOTRONIK STERILIZATION PROTOCOL 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
SYSTEM EXPLANTED DUE TO INFECTION. REPLACED IN 2006 WITH NEW SYSTEM. OTHER DEVICES ASSOCIATED WITH THIS SYSTEM: LUMOS DR-T, MDR# 06-0121. SELOX SR 45,MDR# 06-0122.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KENTROX SL-S 65/16 | TACHYCARDIA LEAD | LWS | BIOTRONIK GMBH AND CO | 342 391 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization |