BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991513 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08077
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN ATTEMPTING TO ACCESS THE VEIN, THE INTRODUCER TIP GOT HUNG UP AND WAS DEFORMED. ANOTHER INTRODUCER WAS USED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO IMPLANT A RIGHT ATRIAL (RA) LEAD IN THE TORTUOUS VENOUS ANATOMY. THE LEAD HAD A 90 DEGREE ANGLE WITH SOME PRESSURE APPLIED TO IT. WHEN THE STYLET WAS PULLED BACK, THE STYLET WAS KINKED AT A 90 DEGREE ANGLE. THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER STYLET INTO THE LEAD, AND WAS UNABLE TO GET THE STYLET DOWN THE LEAD. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470423 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR