BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2042296 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01487
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    March 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL INSPECTION REVEALED DRIED BODY TISSUE IN THE HELIX HOUSING. AS A RESULT, THE STYLET INSERTION TEST AND THE HELIX MECHANISM TEST WERE NOT SUCCESSFUL. THE ELECTRICAL CONTINUITY AND INSULATION INTEGRITY WERE TESTED AND FOUND TO BE APPROPRIATE. AS A RESULT, THE CAUSE OF THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. IF RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD WAS EXHIBITING LOSS OF CAPTURE. DURING THE LEAD REVISION PROCEDURE, IT WAS DISCOVERED THAT THE LEAD WAS DISLODGED. AS A RESULT, THIS LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 4087| 4136| 4088| 1298| S606