BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 3

    MDR report key: 2040738 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01201
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    September 5, 2006
    Report Date
    February 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION CONFIRMED THAT THE OUTER INSULATION, OUTER COIL WIRE CLADDING AND CORE, AND THE INNER COIL WIRE CASING AND CORE WERE ALL CONSISTENT WITH THE SPECIFIED MATERIALS FOR EASYTRAK 3, MODEL 4548 LEADS. THE LEAD WAS SEVERELY STRETCHED WITH MULTIPLE FRACTURES OF THE CONDUCTOR COILS FROM APPROXIMATELY 860-876 MM. NOTE, THIS MODEL LEAD IS ONLY 80CM AS MANUFACTURED. A SINGLE OUTER COIL WIRE WAS FOUND TO BE FRACTURED WITH ONLY THE PROXIMAL SIDE FOUND AND THE DISTAL SIDE LIKELY WITHIN THE ELECTRODE. EVIDENCE OF TORSIONAL OVERLOAD WAS FOUND ON THE OUTER COIL FRACTURE. TWELVE INNER COIL FRACTURE SURFACES WERE FOUND INDICATING A TOTAL OF SIX FRACTURES, BUT WHICH SIDES CORRESPONDED TO ONE ANOTHER COULD NOT BE DETERMINED. TEN OF THE FRACTURE SURFACES WERE EXAMINED FOR FRACTOGRAPHY WITH EACH OF THEM SHOWING INDICATIONS OF TORSIONAL OVERLOAD AND ONE WIRE SHOWED EVIDENCE OF TORSIONAL SHEAR BANDS. THIS DAMAGE WAS DETERMINED TO BE PROCEDURALLY INDUCED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS PREVIOUSLY ABANDONED LEAD LOOKED AS THOUGH IT MIGHT HAVE A FRACTURE. DETAILED ANALYSIS IS BEING PERFORMED AT THIS TIME TO DETERMINE THE POTENTIAL CAUSE OF FRACTURE. THIS REPORT WILL BE UPDATED UPON ANALYSIS COMPLETION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE IN ALL CONFIGURATIONS. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NEW INFORMATION WAS RECEIVED, DURING A RECENT DEVICE UPGRADE PROCEDURE, THIS PREVIOUSLY ABANDONED LEAD WAS EXPLANTED AND RETURNED WITHOUT ANY FURTHER ALLEGATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4548

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 4548| 4087| 4538| 4542| 0184| H177