BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173229 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10652
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS ATTEMPTED AND NOT USED. DURING THE IMPLANT PROCEDURE, THE VENTRICULAR LEAD WAS HOOKED UP TO THE DEVICE, MULTIPLE ATTEMPTS TO INSERT AND REMOVE THE LEAD IT EXHIBITED HIGH OUT OF RANGE SHOCKING IMPEDANCES OF GREATER THAN 125 OHMS. AS A RESULT THE DEVICE WAS NOT USED AND THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 4469| 0157| E110| A155