BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3951033 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-12044
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    November 13, 2013
    Report Date
    March 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED SEVERED IN TWO SEGMENTS TOTALING 882MM. A PORTION OF THE LEAD APPEARED TO BE MISSING AS ANOTHER LEAD WITH THE SAME MODEL WAS MEASURED TOTALING 900MM IN LENGTH. LASER EXTRACTION DAMAGE WAS NOTED IN SEVERAL PLACES ON THE LEAD BODY BY EVIDENCE OF MELTED INSULATION AND CONDUCTOR MATERIAL. DETAILED ANALYSIS CONFIRMED THE CONDUCTOR COIL WAS FRACTURED APPROXIMATELY 300MM FROM THE TERMINAL PIN (RIGHT AT THE SEVERED LOCATION). THE LOCATION OF THE DAMAGE SITE SUGGESTS THE FRACTURE WAS A RESULT OF STRESS JUST DISTAL TO THE SUTURE SLEEVE TIE DOWN; WHICH MAY HAVE BEEN IN OR NEAR THE CLAVICLE/FIRST RIB REGION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IN-OFFICE APPOINTMENT IN EARLY-(B)(6) 2014, THIS LEFT VENTRICULAR (LV) LEAD WAS DISPLAYING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS AND NO CAPTURE. A REVIEW OF THE DAILY MEASUREMENTS SHOWED IMPEDANCES WERE GREATER THAN 2000 OHMS STARTING IN (B)(6) 2013. THE PREVIOUS OFFICE VISIT, TWO MONTHS PRIOR, SHOWED NORMAL IMPEDANCES OF 493 AND APPROPRIATE CAPTURE THRESHOLDS. THE PATIENT WAS THEN REFERRED TO A CARDIAC SURGEON AND A LEAD REPLACEMENT PROCEDURE WAS PERFORMED. A CHEST X-RAY WAS TAKEN WHICH SHOWED A LEAD FRACTURE ADJACENT TO THE PULSE GENERATOR IN THE LEFT INTERCLAVICLE REGION. THE LEAD WAS EXPLANTED AND RETURNED FOR LABORATORY ANALYSIS. OTHER THAN THE LEAD REVISION PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427604 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 4470| 4543| 0185| H217| N051