BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE

    MDR report key: 3864822 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01793
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 6, 2013
    Report Date
    March 10, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S WHERE A SIMILAR 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 AN IMPLANT PROCEDURE, THEY WERE UNABLE TO IMPLANT THE LEFT VENTRICULAR LEAD. THE REASON THE LEAD WAS UNABLE TO FIXATE IN THE DESIRED LOCATION WAS REPORTED AS, ¿FAILURE OF TRANSSEPTAL, UNABLE TO CROSS DILATOR¿. THE PATIENT IS ENROLLED IN (B)(6) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338549 SELECTSECURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 3830

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR