BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1946217 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-23814
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 15, 2010
    Report Date
    June 21, 2024
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION IN (B)(6) 2010 THAT THIS PATIENT'S LATITUDE MONITORING SYSTEM DETECTED A RED ALERT (HIGH SHOCK IMPEDANCE). THE CLINIC NURSE AND BOSTON SCIENTIFIC'S REGIONAL MANAGER WERE NOTIFIED. SUBSEQUENTLY, THE CLINIC NURSE CONTACTED TECHNICAL SERVICES TO DISCUSS THE SHOCK IMPEDANCE TREND FOR THIS LEAD. THE CLINIC NURSE REPORTED THAT THIS LEAD HAD EXHIBITED A HIGH SHOCK IMPEDANCE ISSUE APPROXIMATELY ONE YEAR AGO. THE PATIENT WAS SEEN IN-CLINIC AT THAT TIME AND THE LEAD WAS EVALUATED. NO ABNORMALITIES WERE IDENTIFIED AND NO INTERVENTION WAS REPORTED. THE CLINIC NURSE INFORMED TECHNICAL SERVICES THAT ELECTROGRAM NOISE IS NOW SEEN ON THE RIGHT VENTRICULAR (RV) SHOCK CHANNEL. HOWEVER, THERE IS NO ELECTROGRAM NOISE SEEN ON THE RV PACE/SENSE CHANNEL. TECHNICAL SERVICES SUGGESTED THAT THE PATIENT SHOULD BE SEEN AT THE CLINIC TO PERFORM PATIENT ISOMETRICS/VALSALVA/POCKET MANIPULATION TESTING TO SEE IF THE ELECTROGRAM NOISE AND/OR ABNORMAL IMPEDANCE MEASUREMENTS CAN BE OBTAINED. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE PATIENT HAS BEEN SCHEDULED FOR AN IN-CLINIC EVALUATION OF THE SYSTEM. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION IN (B)(6) 2010 THAT THIS PATIENT'S LATITUDE MONITORING SYSTEM DETECTED ANOTHER RED ALERT (HIGH SHOCK IMPEDANCE). THE CLINIC NURSE WAS AWARE OF THE RED ALERT AND THE LOCAL REPRESENTATIVE WAS CONTACTED. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THIS DEVICE AND LEAD SYSTEM WAS CHECKED AND NO ABNORMALITIES WERE IDENTIFIED. THE PHYSICIAN HAS ELECTED TO CONTINUE MONITORING OF THIS PATIENT'S DEVICE AND LEAD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male 0185| 4087| E110| T127| T127| E110| 4087| 0185