FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 3913561
·
Received July 3, 2014
Report
- Report Number
- 2124215-2014-12431
- Event Type
- Injury
- Date Received
- July 3, 2014
- Date of Event
- May 30, 2014
- Report Date
- May 30, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 EXHIBITED A CONDUCTOR FRACTURE AT THE SUTURE SLEEVE BECAUSE THE SUTURE WAS TOO TIGHT. REVISION PROCEDURE WAS PERFORMED TO REPLACE THE LEAD. THE LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE LEAD IS NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391488 | EASYTRAK 2 | IMPLANTABLE LEAD | NIK | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | 0185| 4543| 4480| P143 |