BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2203393 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01306
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 2, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DYB
    PMA / PMN Number
    K854559
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE INTRODUCER WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE 4196 LEAD WAS NOT RETURNED WITH THE INTRODUCER. THE TRANSVALVULAR INSERTION TOOL (TVI) WAS NOT RETURNED. IT WAS ALSO APPARENT THAT THE TVI TOOL HAD NOT BEEN USED ON THE DILATOR WHICH WOULD HAVE HELPED THE LEAD GAIN ACCESS INTO THE DILATOR AND ADVANCE THE LEAD THROUGH THE INTRODUCER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WOULD NOT ADVANCE THROUGH THE INTRODUCER. A NEW INTRODUCER WAS USED AND THE LEAD WAS ADVANCED AND IMPLANTED. NO PATIENT COMPLICATIONS HAVE OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE PERMANENT LEAD INTRODUCER DYB MEDTRONIC, INC. 6209 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other 6947 IMPLANTABLE TACHY LEAD