FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 3082786
·
Received April 29, 2013
Report
- Report Number
- 2124215-2013-06609
- Event Type
- Injury
- Date Received
- April 29, 2013
- Date of Event
- March 21, 2013
- Report Date
- March 21, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- 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 LEFT VENTRICULAR (LV) LEAD WAS DISLODGED. A REPLACEMENT LV LEAD WAS IMPLANTED BY THE PHYSICIAN. THIS LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183423 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| L| R | N160| 4555| 4135| 0292| 4543 |