BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3052767 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05219
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION CONFIRMED INSULATION DAMAGE IN ADDITION TO A FRACTURED INNER CONDUCTOR COIL. LABORATORY ANALYSIS DETERMINED THAT DUE TO THE LOCATION AND TYPE OF DAMAGE, IT APPEARS IT WAS MOST LIKELY CAUSED BY ENTRAPMENT IN THE CLAVICLE/FIRST RIB REGION. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED AND IS BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE LEAD WILL BE RETURNED FOR EVALUATION AND THIS PRODUCT ISSUE WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS, NO CAPTURE DESPITE HIGH DEVICE OUTPUTS AND NO PACING IN EITHER CONFIGURATION. A REVISION PROCEDURE WAS PERFORMED AND AN INSULATION BREAK WAS NOTED AT THE INSERTION SITE. THEREFORE, THE LEAD WAS REMOVED FROM SERVICE AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154902 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization 4086| 4035| 1290