BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 3

    MDR report key: 2053608 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04404
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEFT VENTRICULAR LEAD REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AND DIAPHRAGMATIC STIMULATION. THE PACING CONFIGURATION OF THE LEAD WAS ABLE TO BE REPROGRAMMED SO THAT THE LEAD CAPTURED THE LEFT VENTRICLE; HOWEVER, DIAPHRAGMATIC STIMULATION WAS STILL PRESENT. LEFT VENTRICULAR LEAD MIGRATION OR DISLODGEMENT WAS SUSPECTED. A LEAD REVISION PROCEDURE MAY BE PERFORMED IN THE NEAR FUTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R