FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 4132362
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-17611
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- July 17, 2014
- Report Date
- July 17, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENTS. A FRACTURE PROXIMAL TO THE SUTURE SLEEVE WAS CONFIRMED VIA X-RAY. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE THE LV LEAD WAS EXPLANTED AND WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612956 | EASYTRAK 2 | IMPLANTABLE LEAD | NIK | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| L| R | MISMATCH| T177| H217| 4543| N141| 4555| 0185| H210 |