FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 2920926
·
Received January 17, 2013
Report
- Report Number
- 2124215-2013-01319
- Event Type
- Injury
- Date Received
- January 17, 2013
- Date of Event
- December 14, 2012
- Report Date
- December 10, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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 EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCES AND WAS FOUND TO BE FRACTURED. THE PHYSICIAN SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED THE LEAD. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26387 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| L| R | H215| MISMATCH| N141| 4470| 4517| 0185 |