FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 2171174
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-09765
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- June 3, 2011
- Report Date
- June 3, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISLODGED AFTER THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT SURGERY (CABG). THE LEAD WAS EXPLANTED AND A NEW LEAD WAS PLACED. THE EXPLANTED PRODUCT WAS DISCARDED AFTER THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | 4542| 4470| 0158| 4549| 4591| H170| N119 |