BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2171304 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09845
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 4, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS ONE DAY AFTER THE IMPLANT PROCEDURE. TECHNICAL SERVICES (TS) DISCUSSED A POSSIBLE CONNECTION ISSUE AND RECOMMENDED PERFORMING AN X-RAY TO CONFIRM THE LEADS INTEGRITY AND CONNECTION. THE FIELD REPRESENTATIVE INDICATED HE COULD NOT VISUALIZE THE TERMINAL PIN PAST THE CONNECTOR BLOCK AS EASILY AS HE SHOULD HAVE SEEN THE TERMINAL PIN. TS ALSO DISCUSSED THE POSSIBILITY OF ELECTROMAGNETIC INTERFERENCE (EMI) CAUSING THIS AS WELL AS TESTING OTHER SHOCK VECTORS. THE FIELD REPRESENTATIVE INDICATED THAT RIGHT VENTRICULAR (RV) COIL TO CAN CONFIGURATION RESULTING IN GOOD IMPEDANCE MEASUREMENTS AND THE PHYSICIAN WAS SATISFIED WITH THIS RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1