BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2864830 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17520
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. (B)(4) IMPLANTABLE DEFIBRILLATOR (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS NOT CAPTURING. DURING THE PROCEDURE TO REPLACE THE ATRIAL LEAD, ANOTHER LEAD WAS ATTEMPTED AND NOT USED BECAUSE THE LEAD WAS MOVED DURING THE PROCEDURE TO A "NON-FUNCTIONAL POSITION" AND THE PHYSICIAN ELECTED NOT TO USE IT. THE ATRIAL LEAD WAS CAPPED 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 NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD