FDA Adverse Event
Malfunction
Summary report: N
EASYTRAK 2
MDR report key: 2041629
·
Received April 6, 2011
Report
- Report Number
- 2124215-2011-00881
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- January 12, 2011
- Report Date
- January 12, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED AND RESUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE SYSTEM HAD A LEFT VENTRICULAR PACING IMPEDANCE MEASUREMENT GREATER THAN 2000 OHMS MULTIPLE OCCASIONS IN (B)(6) 2010. THIS WAS OBSERVED BY THE REMOTE MONITORING SYSTEM. SINCE (B)(6) 2010 MEASUREMENTS HAVE BEEN NORMAL AROUND 600 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONTACTED WHOM DISCUSSED A POSSIBLE LEAD, CONNECTION, OR INTERMITTENT ISSUE. THE CLINIC WILL CONTINUE TO MONITOR. ALL PRODUCTS REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.
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 | 73 YR | 4543| 0185| H227| 4470 |