FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 3212697
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09447
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 30, 2013
- Report Date
- July 2, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE ALLEGATION OF A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS CONFIRMED. THE LEAD ANODE CONDUCTOR COIL WAS FRACTURED APPROXIMATELY 400 MILLIMETERS FROM THE TERMINAL PIN IN THE LOCATION AROUND THE SUTURE SLEEVE TIE DOWN SITE.
Additional Manufacturer Narrative · 1
THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO DISPLAYING HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314453 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10380 DA | Hospitalization| L| R | N119| 4542| 4470| 4543| 0185 |