BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2546265 · Received April 18, 2012

    Report

    Report Number
    MW5025134
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Date of Event
    March 20, 2012
    Report Date
    April 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MTD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CONSTELLATION MULTIPLE ELECTRODE RECORDING AND PACING CATHETER WAS PLACED IN LEFT ATRIUM DURING EP PROCEDURE. APPROXIMATELY 1 HOUR INTO PROCEDURE DR. NOTICED THAT ONE OF THE TINED ELECTRODES HAD BROKEN LOOSE FROM ONE END OF THE CONSTELLATION BASKET. THE CATHETER WAS IMMEDIATELY REMOVED FROM THE PT AND A NEW CATHETER WAS PLACED IN THE LEFT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CONSTELLATION ELECTRODE MTD BOSTON SCIENTIFIC 14768817

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR