BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3040682 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00552
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED DRIED BODY FLUID IN THE LEAD LUMEN, THE CONDUCTOR COILS WERE SLIGHTLY STRETCHED NEAR THE TIP AND THE TINES WERE MISSING FROM THE LEAD, APPEARING TO BE CUT OFF. FURTHER TESTING CONFIRMED THE LEAD TO BE ELECTRICALLY CONTINUOUS.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO ALLOW FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE SYSTEM REPORTED SHORTNESS OF BREATH SYMPTOMS. AN ECHOCARDIOGRAM WAS PERFORMED, DISPLAYED A DECREASED EJECTION FRACTION FROM 55% TO 30%. SUBSEQUENT DEVICE INTERROGATION DISPLAYED AN INCREASE IN THE LEFT VENTRICULAR (LV) LEAD THRESHOLD AND RIGHT VENTRICULAR (RV) PACING MORPHOLOGY. A CHEST X-RAY REVEALED AN LV LEAD DISLODGEMENT. A REVISION PROCEDURE WAS PERFORMED AND THE LV LEAD WAS EXPLANTED. DURING THE PROCEDURE, THE DEVICE WAS ELECTIVELY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143871 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 0184| 4537| 4542| 4591| H210| N161| 4086