BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990618 · Received August 8, 2014

    Report

    Report Number
    3008973940-2014-00273
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. STYLET INSERTION TEST RESULT WAS FAILED. TEST PERFORMED 3 TIMES USING THE 3 STYLETS RECEIVED IN BAG WHICH WERE NOT IN DISPENSER. VISUAL INSPECTION FOUND BLOOD OBSTRUCTED IN DISTAL CONDUCTOR USING DESTRUCTIVE TESTING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DOCTOR WAS NOT ABLE TO INTRODUCE THE STYLET FLUENTLY INTO THE LEAD. THE LEAD WAS ATTEMPTED AND NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467217 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR