BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790410 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14135
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 2, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. EVALUATION SUMMARY: (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND THE HELIX/LOBE WAS DISTORTED/BENT. IT WAS NOTED THAT ALL OF THE CONDUCTORS WERE STRETCHED, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEAD IMPLANT ATTEMPT, THE LEAD WOULD NOT EASILY ADVANCE INTO THE SUPERIOR VENA CAVA DUE TO A SLIGHT OCCLUSION OF THE VASCULATURE. DURING THE PASSING OF THE LEAD, IT WAS NOTED THAT THE HELIX MAY HAVE BEEN SLIGHTLY DEPLOYED. THE HELIX WAS RETRACTED AND WAS REMOVED WITH MUCH DIFFICULTY FROM THE VESSEL AS IT APPEARED TO "GET STUCK" WHEN THE LEAD WAS FINALLY REMOVED, THE HELIX WAS DEPLOYED AND STRETCHED OUT AS IF IT HAD GOTTEN CAUGHT ON SOMETHING. A DIFFERENT LEAD WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other