BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2791487 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03268
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTF
    PMA / PMN Number
    K854559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT, THE ABILITY TO ADVANCE THE CATHETER THROUGH THE INTRODUCER WAS DIFFICULT DUE TO THE INTRODUCER BEING TOO LONG. THE PATIENT WAS ENROLLED IN THE DELIVERY FOR (B)(4) STUDY. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE PERMANENT LEAD INTRODUCER DTF MEDTRONIC, INC. 6208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other