BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964507 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01984
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 17, 2012
    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 INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2003 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED DEVICE CHANGE OUT PROCEDURE, THE ATRIAL LEAD IMPEDANCE MEASURED HIGH WHEN TESTED THROUGH THE ANALYZER AND THE IMPEDANCE WAS UNABLE TO BE DETERMINED WHEN MEASURED THROUGH THE NEW DEVICE. IT WAS ALSO NOTED THAT THE IMPEDANCE WAS UNABLE TO BE ASSESSED THROUGH THE PATIENT'S CHRONIC DEVICE AS IT HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) APPROXIMATELY ONE YEAR PRIOR TO CHANGE OUT. THE ATRIAL LEAD WAS LEFT PLUGGED IN TO THE REPLACEMENT DEVICE AND THE DEVICE WAS PROGRAMMED TO VVIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68464 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR