ENDOTAK RELIANCE
Report
- Report Number
- 2124215-2010-23820
- Event Type
- Malfunction
- Date Received
- January 6, 2011
- Date of Event
- November 27, 2010
- Report Date
- October 26, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
ACCORDING TO BOSTON SCIENTIFIC'S MEDICAL RECORDS, THIS DEVICE AND LEAD SYSTEM REMAIN IN-SERVICE. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR PRODUCTS ARE RETURNED FOR ANALYSIS.
TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR PRODUCTS ARE RETURNED FOR ANALYSIS.
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE PHYSICIAN ELECTED TO CONTINUE MONITORING THIS PATIENT'S DEVICE/LEAD SYSTEM.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT LATITUDE MONITORING SYSTEM DETECTED A RED ALERT (HIGH RIGHT VENTRICULAR (RV) SHOCK IMPEDANCE. THE LOCAL REPRESENTATIVE AND THE CLINIC WERE NOTIFIED OF THE ALERT. THE LOCAL REPRESENTATIVE HAD CONTACTED TECHNICAL SERVICES TO DISCUSS THIS ALERT AND WAS INFORMED THAT THIS RV DEFIBRILLATION LEAD WAS A SINGLE COIL AND HIGHER SHOCK IMPEDANCE COULD BE EXPECTED. TECHNICAL SERVICES INFORMED THE LOCAL REPRESENTATIVE THAT THE SHOCK IMPEDANCE HAS GRADUALLY INCREASE FROM THE 80 OHM RANGE ((B)(6) 2010) AND IS NOW IN THE 90-120 OHM RANGE. TECHNICAL SERVICES DISCUSSED NONINVASIVE TESTING INCLUDING DELIVERY OF A MINIMUM AND MAXIMUM ENERGY SHOCK TEST. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE CLINIC AND PHYSICIAN ARE AWARE OF THE SITUATION. THE PHYSICIAN PLANS TO CONTINUE MONITORING AND THE PATIENT HAS NOT BEEN SCHEDULED FOR ANY ADDITIONAL TESTING.
SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE CLINIC NURSE TO DISCUSS THE SHOCK IMPEDANCE HISTORY OF THIS PATIENT'S LEAD. THE CLINIC NURSE INFORMED TECHNICAL SERVICES THAT THE SHOCK IMPEDANCE MEASUREMENT AT IMPLANT WAS 72 OHMS AND HAS BEEN SHOWING VARIATIONS IN IMPEDANCE VALUES FROM 90 OHMS TO 120 OHMS. THERE WAS ONE SHOCK IMPEDANCE MEASUREMENT THAT WAS GREATER THAN 125 OHMS. THE CURRENT SHOCK IMPEDANCE MEASUREMENT WAS 99 OHMS. THE LAST DELIVERED SHOCK OCCURRED ON SEPTEMBER 8, 2010 AND THE RECORDED SHOCK IMPEDANCE MEASUREMENT WAS 71 OHMS. TECHNICAL SERVICES DISCUSS THAT A SINGLE COIL SYSTEM CAN BE ON HIGHER SIDE AND THE PHYSICIAN COULD CONSIDER DELIVERY OF A COMMANDED SHOCK TO BETTER ASSESS THE INTEGRITY OF THE DEVICE/LEAD SYSTEM.
SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION IN (B)(6) 2011 THAT THIS PATIENT'S LATITUDE MONITORING SYSTEM DETECTED A RED ALERT (HIGH SHOCK IMPEDANCE). THE LOCAL REPRESENTATIVE AND CLINIC RED ALERT VOICE MESSAGE CENTER WERE NOTIFIED OF THE ALERT. THE LOCAL REPRESENTATIVE CONTACTED LATITUDE CUSTOMER SUPPORT TO REPORT THAT THE CLINIC WAS AWARE OF THE ALERT. THE LATITUDE DATA UPLOAD WAS REVIEWED BY THE CLINIC NURSE FROM THE LATITUDE PHYSICIAN WEBSITE.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S MONITORING SYSTEM DETECTED ANOTHER RED ALERT (HIGH SHOCK IMPEDANCE) IN (B)(6) 2011. THE LOCAL REPRESENTATIVE AND ON-CALL NURSE PRACTITIONER WERE NOTIFIED OF THE ALERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | 0170| 4591| N119| 4135| 4542 |