BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 1852639 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14341
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 13, 2010
    Report Date
    January 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THE LEAD WAS RETURNED SEVERED INTO TWO SEGMENTS. THE FIRST SEGMENT WAS MISSING THE TERMINAL PIN, AND THE SECOND SEGMENT WAS MISSING THE TIP OF THE LEAD. NUMEROUS ASPECTS OF INDUCED DAMAGE WERE NOTED VISUAL INCLUDING STRETCHED CONDUCTOR COILS AND ELECTRO CAUTERY DAMAGE. NO FRACTURE WAS FOUND IN EITHER SEGMENT DURING X-RAY ANALYSIS. NO OTHER TESTING WAS PERFORMED, AND THE FIELD ALLEGATION COULD NOT BE CONFIRMED BY VISUAL ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED. 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

    THE LEAD REMAINS IN SERVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE BUT ELECTRONICALLY DEACTIVATED. NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT AT A FOLLOW UP ONE YEAR LATER LOSS OF CAPTURE WAS NOTED ON THE LEFT VENTRICULAR (LV) LEAD, IN ADDITION TO THE CONTINUED HIGH PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD EXHIBITED HIGH, OUT OF RANGE PACING IMPEDANCES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SURGICAL INTERVENTION WAS PERFORMED TO SURGICALLY ABANDON AND REPLACE THIS LEFT VENTRICULAR (LV) LEAD. IT WAS NOTED THAT THE LEAD ALSO DISPLAYED RISING THRESHOLDS RESULTING IN LOSS OF CAPTURE IN ADDITION TO THE HIGH, OUT OF RANGE PACING IMPEDANCES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4525

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R N118| 4086| 4525| H179| 0158