FDA Adverse Event
Injury
Summary report: N
EASYTRAK 3
MDR report key: 3210085
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-06859
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 16, 2013
- Report Date
- April 16, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- PMA / PMN Number
- P010012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS DISCARDED AT THE HOSPITAL AND WILL NOT BE RETURNED. 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 ONE DAY POST-IMPLANT, THIS LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310372 | EASYTRAK 3 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | 4592| W173| 4549| 4480| 4457| 4543 |