BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3922055 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13011
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS DISLODGED. THE LEAD WAS EXPLANTED AND WAS REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401086 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R K173| 4469| 4086| 4087