BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 3

    MDR report key: 3951184 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-14287
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    March 6, 2008
    Report Date
    June 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, THERE HAS BEEN NO FURTHER INFORMATION AVAILABLE AT THIS TIME. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS ATTEMPTED BUT IT EXHIBITED LEAD DAMAGE OF AN UNKNOWN NATURE. THIS LEAD WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427529 EASYTRAK 3 IMPLANTABLE LEAD LWP CPI - DEL CARIBE 4548

    Patients

    Seq Age Sex Outcome Treatment
    1 4548| 4555| 4543| H140