BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2913255 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00378
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    October 26, 2012
    Report Date
    December 11, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 EXHIBITED OUT OF RANGE PACING IMPEDANCES. THE IMPEDANCES IN THE UNIPOLAR CONFIGURATION WERE DETERMINED TO BE NORMAL. THE ISSUE WAS FOUND TO BE RELATED TO THE RIGHT VENTRICULAR (RV) LEAD'S RV RING. LATER INFORMATION INDICATES THAT THIS PATIENT UNDERWENT A REVISION PROCEDURE AND THIS LEAD EXHIBITED OUT OF RANGE PACING IMPEDANCES IN THE BIOPOLAR CONFIGURATION GREATER THAN 2,500 OHMS. THE FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION REGARDING THIS CLINICAL OBSERVATION; HOWEVER, NO FURTHER INFORMATION WAS ABLE TO BE BROUGHT FORTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20716 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R 0148| N118| H179| 1861| 4015| 4517