FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 2151686
·
Received July 6, 2011
Report
- Report Number
- 2124215-2011-07703
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 4, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- PMA / PMN Number
- P010012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AVAILABLE INFORMATION SUGGESTS THAT THIS EPICARDIAL LEAD REMAINS ACTIVELY IN SERVICE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS EPICARDIAL LEAD MAY HAVE CAUSED OR CONTRIBUTED TO PERFORATION OF THE PATIENT IN AN UNSPECIFICED LOCATION AS OF THIS DATE. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR MORE INFORMATION BUT NONE IS AVAILABLE TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Required Intervention | 5076| H175| H179| 0184| 4518 |