BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950256 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22345
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 14, 2010
    Report Date
    November 14, 2010
    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

    AN INVASIVE PROCEDURE WAS PERFORMED AND THE RATE/SENSE PORTION OF THE LEAD WAS CAPPED. A NEW RATE/SENSE LEAD WAS SUCCESSFULLY IMPLANTED. THE SHOCK PORTION OF THIS LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED NOISE ON THE RATE/SENSE CHANNEL. THE PATIENT EXPERIENCED A SYNCOPAL EPISODE DUE TO THE NOISE BEING OVERSENSED. LOW PACE IMPEDANCE MEASUREMENTS WERE ALSO OBSERVED. IT WAS REPORTED THE PATIENT IS PACER DEPENDENT.

    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 89 YR Required Intervention MISMATCH| 1290| H217| 6987| 4549| 0184| 4087| 4086