FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 3051368
·
Received April 10, 2013
Report
- Report Number
- 2124215-2013-03487
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 14, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- 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 DURING AN OFFICE VISIT, THIS LEFT VENTRICULAR (LV) LEAD WAS FOUND TO HAVE BEEN FRACTURED. THE LEAD WAS LATER CAPPED DURING A DEVICE DOWNGRADE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153115 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Hospitalization| L| R | H217| 4543| 0185 |