FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 1850239
·
Received October 1, 2010
Report
- Report Number
- 2124215-2010-15932
- Event Type
- Injury
- Date Received
- October 1, 2010
- Date of Event
- July 6, 2010
- Report Date
- July 6, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- PMA / PMN Number
- P010012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THIS LV LEAD WAS PERFORMED AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. DETAILED INSPECTION AND ANALYSIS OF THIS LEAD FOUND THAT THE LEAD WAS FRACTURED. FINAL ANALYSIS CONFIRMED THAT THE LEAD INCURRED DAMAGE CONSISTENT WITH CLAVICULAR CRUSH. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS EVENT. THIS LV LEAD WAS RETURNED FOR ANALYSIS.
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 | 56 YR | Life Threatening| R | 4543| H177| E110| 6949| 5076| 4538 |