BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2790987 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14482
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 10, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 AND ANALYZED. THE DISTAL CONDUCTOR WAS DISTORTED, AND THE CONNECTOR PIN WAS BENT. BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM AND THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL. THE LEAD APPEARED TO BE DAMAGED AT IMPLANT. THE ANALYST NOTED THAT THE LEAD WAS RECEIVED WITH THE HELIX FULLY RETRACTED. THE HELIX HAD BEEN OVER-RETRACTED, WHICH MOST LIKELY CONTRIBUTED TO THE HELIX ISSUE. WHEN THE HELIX WAS RETRACTED DURING THE PROCEDURE, THE IS-1 CONNECTOR PIN WAS TURNED AND EXCESSIVE NUMBER OF TIMES, RESULTING IN DISTORTION OF THE DISTAL CONDUCTOR WITHIN THE CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE ATRIAL LEAD WAS REPOSITIONED TWICE, AND DURING THE SECOND ATTEMPT AT POSITIONING, IT WAS NO LONGER POSSIBLE TO DEPLOY THE HELIX. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5568

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other