BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2910678 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15323
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 9, 2012
    Report Date
    December 11, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WAS CONFIRMED TO BE FRACTURED 31 CM FROM THE TERMINAL PIN. BASED ON THE ANALYSIS RESULTS, WE SUSPECT THAT FATIGUE OR STRESS IN THE REGION OF THE FRACTURE SITE DUE TO RELATIVE MOTION BETWEEN THE SUTURE SLEEVE AND AN ANATOMICAL FEATURE LED TO THE FRACTURE. THE FRACTURE APPEARS TO BE AT DISTAL END OF THE SUTURE SLEEVE TIE-DOWN AREA. AS A LEAD MOVES IN RESPONSE TO NORMAL HEART RHYTHMS AND BLOOD FLOW, EXTENSIVE FLEXING OVER A PERIOD OF TIME MAY CAUSE FATIGUE OR STRESS, WEAKENING THE COIL, ULTIMATELY RESULTING IN A FRACTURE. THIS CAN OCCUR BETWEEN THE SUTURE SLEEVE AND SOME OTHER PART OF THE ANATOMY. A COMBINATION OF LEAD DESIGN, IMPLANT TECHNIQUES, AND PATIENT ANATOMY AND ACTIVITY LEVEL CONTRIBUTE TO THESE TYPES OF OCCURRENCES.

    Additional Manufacturer Narrative · 1

    UPON RETURN AND ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD WAS FRACTURED. THE PACING IMPEDANCES HAD BEEN INCREASING AND WERE OUT OF RANGE. THE DAMAGE APPEARS TO BE NEAR THE SUTURE SLEEVE. DURING THE EXPLANT OF THE LEAD A PORTION OF THE LEAD WAS SURGICALLY ABANDONED, WHILE THE OTHER PORTION WILL BE RETURNED. A NEW LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16253 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R