FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 3043316
·
Received April 9, 2013
Report
- Report Number
- 2124215-2013-02491
- Event Type
- Injury
- Date Received
- April 9, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 17, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 CAPTURE THRESHOLDS, LOSS OF CAPTURE AND >2000 OHM PACING IMPEDANCES IN ALL PACING VECTORS. THE PHYSICIAN SUSPECTED A LEAD FRACTURE. THIS LEAD WAS SURGICALLY ABANDONED AT THE PATIENT'S GENERATOR CHANGE-OUT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146046 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| L| R | N161| 4136| 0185| H217| 4542| 4592 |