FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 2040758
·
Received April 6, 2011
Report
- Report Number
- 2124215-2011-04101
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- February 11, 2011
- Report Date
- January 11, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. 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 THE PATIENT IMPLANTED WITH THIS LEFT VENTRICULAR (LV) LEAD EXPERIENCED DIAPHRAGMATIC STIMULATION. PROGRAMMING OF THE DEVICE COULD NOT MITIGATE THE STIM. AN INVASIVE LEAD REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS REPOSITIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | 4136| N119| 7120| 4543 |