BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2050753 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05418
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 24, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WAS DISTORTED/BENT. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INITIAL IMPLANT ATTEMPT, THE RIGHT VENTRICULAR LEAD EXPERIENCED PACING AND SENSING DIFFICULTIES THAT REQUIRED REPOSITIONING. THE HELIX WAS DIFFICULT TO RETRACT, BUT APPEARED TO BE FULLY RETRACTED UNDER FLUOROSCOPIC EXAMINATION. THE LEAD APPEARED TO "HANG UP" AND WITH SOME PRESSURE, THE PHYSICIAN AS ABLE TO FULLY REMOVE THE LEAD. THE LEAD WAS EXAMINED POST IMPLANT AND TISSUE WAS PRESENT ON THE HELIX. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS WERE 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other