FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 2173641
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10721
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 20, 2011
- Report Date
- July 20, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- PMA / PMN Number
- P010012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
OUR RECORDS INDICATE THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATINET WITH THIS LEFT VENTRICULAR (LV) LEAD DEVELOPED AN INFECTION. A REVISION PROCEDURE WILL BE SCHEDULED IN THE NEAR FUTURE TO EXTRACT THE ENTIRE SYSTEM.
Description of Event or Problem · 1
ADDITIONAL INFORMATION INDICATED THIS LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention | 6836| 1763| H210| 1861| 4269| 4543| 4470| 0125| 0074| 0063 |