FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 2053008
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-03858
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- February 18, 2011
- Report Date
- March 1, 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
THIS LV LEAD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT, WHO HAS THIS LEFT VENTRICULAR (LV) LEAD, DEVELOPED BACTERIAL ENDOCARDITIS. PATIENT WAS TREATED, AND THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
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 | N119| 0185| 4068| 4543 |