BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3052732 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05427
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT 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 THE PATIENT IMPLANTED WITH THIS LEFT VENTRICULAR (LV) LEAD EXPERIENCED A SYNCOPAL EPISODE THAT THE PHYSICIAN FELT WAS UNRELATED TO THE IMPLANTED PRODUCT. ADDITIONALLY, THE LV LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE (LOC). X-RAY IMAGING REVEALED THAT THE LEAD HAD PULLED BACK SLIGHTLY FROM THE INITIAL IMPLANT LOCATION. LV OUTPUTS WERE INCREASED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156172 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 1190| 0185| 4076| 4457| N119| 4543