BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922284 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12846
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE DEVICE WITH MODEL NUMBER 6949 IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD A MALFUNCTION, THE LEFT VENTRICULAR LEAD HAD A "ROUGH SURFACE" DUE TO THREE SEPARATE INSULATION BREAKS, AND THE RIGHT VENTRICULAR LEAD EXPERIENCED HIGH IMPEDANCE AND TRIGGERED A PATIENT ALERT. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS SUSPECTED TO BE FAILING, AND HEME WAS NOTED IN THE LEFT VENTRICULAR LEAD. ALL THREE LEADS WERE EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, THE PHYSICIAN NOTED THAT THE PATIENT WAS FULLY OCCLUDED ON THE LEFT SIDE. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB