BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992720 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09705
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. PRODUCTS: 5076-58 LEAD IMPLANTED 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS MOVED FROM THE LEFT SIDE TO THE RIGHT SID E DUE TO RADIATION THERAPY. THE NEXT DAY, THE RIGHT ATRIAL (RA) LEAD THRESHOLDS HAD RISEN; A CHEST X-RAY CONFIRMED THAT THE LEAD HAD PULLED BACK. DURING THE REVISION PROCEDURE, THE PHYSICIAN NOTED THAT HE HAD FAILED TO TIE THE LEADS DOWN WITH SUTURE SLEEVES DURING THE INITIAL IMPLANT. THE LEADS WERE SUBSEQUENTLY TIED DOWN, AND THE PHYSICIAN INCREASED THE OUTPUT ON THE RA LEAD WITH NORMAL DEVICE FUNCTION. THE LEAD REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470317 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R ADDR01 IPG