BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2791413 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15127
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 23, 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, ANALYZED AND THE DISTAL CONDUCTOR WAS DISTORTED. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT PROCEDURE, THE HELIX WOULD NOT EXTEND. THE LEAD WAS ATTEMPTED AND NOT USED. ANOTHER 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5568

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other