BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2811925 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17395
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 10, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR STRETCHED, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE INNER INSULATION WAS KINKED/BUCKLED, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THE LEAD APPEARED DAMAGED AT IMPLANT AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THERE WAS A VERY TIGHT CLAVICLE AREA AND IT WAS NOT POSSIBLE TO MANIPULATE THE RIGHT ATRIAL (RA) LEAD. ALSO, THE RA LEAD MAY HAVE BEEN DAMAGED WHILE PULLING IT OUT TO DO A NEW SUBCLAVIAN STICK. THE RA LEAD WAS NOT IMPLANTED AND A DIFFERENT LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN 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 80 YR Other