FDA Adverse Event
Injury
Summary report: N
EASYTRAK 3
MDR report key: 3223544
·
Received July 12, 2013
Report
- Report Number
- 2124215-2013-10059
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 3, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- PMA / PMN Number
- P010012
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- PHYSICIAN
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 BRADY LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THIS BRADY LEAD WAS BROKEN IN HALF DURING THE EXPLANT PROCEDURE. THIS LEAD WAS CAPPED AND SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321944 | EASYTRAK 3 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| L| R | N119| H177| 5071| 4549| 5568| 0158 |