BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1946136 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20308
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 15, 2010
    Report Date
    May 8, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER EVALUATION WAS PERFORMED AT THIS TIME. RECORDS INDICATE THIS LEAD AND DEVICE REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND RECORDS INDICATE THIS SYSTEM REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THESE PRODUCTS REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS LEAD AND DEVICE WILL CONTINUE TO BE MONITORED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING A LATITUDE RED ALERT WAS ISSUED FOR THIS LEAD AND ICD DUE TO SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE PATIENT WAS BROUGHT INTO CLINIC FOR FURTHER EVALUATION. DURING TESTING SHOCK IMPEDANCE MEASUREMENTS WERE AROUND 100 OHMS AND NO NOISE WAS SEEN ON THE SHOCK CHANNEL. A MAXIMUM ENERGY SHOCK WAS DELIVERED AND AGAIN ACCEPTABLE MEASUREMENTS WERE OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE AGAIN OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. AN INVASIVE PROCEDURE WAS PERFORMED AND IT WAS DISCOVERED THAT THE RIGHT VENTRICULAR RATE/SENSE TERMINAL PIN WAS NOT COMPLETELY SEATED IN THE PORT. ADDITIONAL SLACK WAS GIVEN TO THE LEAD AND WAS RE-INSERTED INTO THE PORT WHICH RESOLVED THE HIGH MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 65 YR Required Intervention 4136| E110| 0185