BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2913308 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17345
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. 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 HAD DECREASED IMPEDANCE MEASUREMENTS AND NO CAPTURE AT MAXIMUM OUTPUT IN ALL CONFIGURATIONS. IT WAS CONFIRMED THAT THE LEAD HAD DISLODGED. AS A RESULT, A REVISION PROCEDURE WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20361 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR N162| 1688TC| 0295| 4542