FDA Adverse Event
Injury
Summary report: N
KENTROX RV 65
MDR report key: 1020497
·
Received March 28, 2008
Report
- Report Number
- 1028232-2008-00349
- Event Type
- Injury
- Date Received
- March 28, 2008
- Date of Event
- February 20, 2008
- Report Date
- March 7, 2007
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS LEAD WAS EXPLANTED DUE TO A LEAD FRACTURE. A NEW SYSTEM WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KENTROX RV 65 | ICD LEAD | LWS | BIOTRONIK GMBH AND CO. | 348090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Hospitalization |