BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2910201 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15547
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    April 10, 2008
    Report Date
    November 29, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THERE WAS BODY FLUID OBSERVED IN THE LUMEN, HOWEVER, THE LEAD TIP AND TINES DISPLAYED NO VISIBLE SIGNS OF DAMAGE. LABORATORY TESTING DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE RESULTED IN THE CLINICAL OBSERVATION OF DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISLODGED SOON AFTER THE LEAD WAS IMPLANTED. AS A RESULT, THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPROGRAMMED AS AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). SUBSEQUENTLY, THE PATIENT'S HEART FAILURE RECENTLY WORSENED REQUIRING A LEAD REVISION PROCEDURE. THE LV LEAD WAS EXPLANTED AND REPLACED DURING THAT PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS RESULT OF THAT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18543 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R 0184| 4271| H220| 1273| 4285| 4543| T165