FDA Adverse Event
Malfunction
Summary report: N
EASYTRAK 2
MDR report key: 1953645
·
Received January 10, 2011
Report
- Report Number
- 2124215-2010-23908
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- December 8, 2010
- Report Date
- December 8, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE SALES REPRESENTATIVE WILL DISCUSS THIS FURTHER WITH THE PHYSICIAN AND WILL INFORM OUR COMPANY SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD WAS EXHIBITING IMPEDANCES MEASUREMENTS GREATER THAN 2000 OHMS WHEN USING THE LEFT VENTRICULAR TIP IN THE CONFIGURATION. THE OTHER CONFIGURATIONS WERE SHOWING NORMAL IMPEDANCE MEASUREMENTS. NO NOISE WITH ISOMETRICS OR POCKET MANIPULATION WAS OBSERVED AND PACING THRESHOLDS WERE NORMAL. A CHEST X-RAY WAS TAKEN LAST MONTH WHICH DID NOT SHOW ANY GROSS LEAD ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | 0184| N119| 4472| 4542 |