BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAYAMED

    MDR report key: 4830171 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06246
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 2, 2015
    Report Date
    March 3, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND 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 PROCEDURE, THE IMPLANTER HAD DIFFICULTIES INSERTING THE LEAD IN THE VEIN. WHEN THE LEAD WAS REMOVED FROM THE PATIENT, THE LEAD APPEARED TO HAVE AN "S" SHAPE CLOSE TO THE DISTAL ELECTRODE AS IF IT WAS DEFORMED. A DIFFERENT LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373878 NAYAMED ELECTRODE, PACEMAKER, PERMANENT DTB MPRI NPX10258

    Patients

    Seq Age Sex Outcome Treatment
    1