BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2910132 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15274
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. 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 LEAD DISPLAYED INCREASED THRESHOLD MEASUREMENTS. A REVISION PROCEDURE WAS INTENDED, HOWEVER PRIOR TO THE PROCEDURE, IT WAS NOTED THIS LEAD'S RING WAS SUSPECTED FRACTURED. THE LEAD WAS REPROGRAMMED TO UNIPOLAR AND ACCEPTABLE MEASUREMENTS WERE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16634 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 4517| H249| 5076| 4096| 6947| H199| H195