FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 2051730
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-03929
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- February 23, 2011
- Report Date
- February 23, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- 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 A REVISION PROCEDURE WAS PERFORMED FOR A LEFT VENTRICULAR (LV) LEAD DISLODGEMENT. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO REPOSITION THE LEAD, THE PHYSICIAN OPTED TO EXPLANT THE LV LEAD. A NEW NON-BOSTON SCIENTIFIC LEAD WAS SUCCESSFULLY IMPLANTED. NO 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 | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| L| R | MISMATCH| 4543| 0185| 4136| N119 |