BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3053260 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04830
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. LABORATORY ANALYSIS NOTED DRIED BODY FLUID ON THE LEAD LUMEN. HOWEVER, VISUAL INSPECTION COULD NOT CONFIRM ANY ISSUE WITH THE LEAD THAT WOULD HAVE LED TO THE CLINICAL OBSERVATION OF DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW-UP APPOINTMENT THIS LEFT VENTRICULAR (LV) LEAD WAS PACING IN THE ATRIUM. A CHEST X-RAY REVEALED THE LV LEAD HAD DISLODGED. AS A RESULT, AN INVASIVE REVISION PROCEDURE WAS PERFORMED. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE LV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS RESULT OF THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155441 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R N140| 4543| 4135| 0295