BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSITE

    MDR report key: 3152382 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01564
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD WITH THE CATHETER COULD NOT BE SUCCESSFULLY IMPLANTED IN THE ATRIUM. THE P HYSICIAN REPLACED THE LEAD WITH A NEW ONE AND USED A NEW SHEATH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253003 SELECTSITE INTRODUCER, CATHETER DYB MEDTRONIC C304S5906 0006062822

    Patients

    Seq Age Sex Outcome Treatment
    1