BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSFIX PU SCR.-IN

    MDR report key: 3151869 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05602
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 10, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), 2010 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY REMOTE TRANSMISSION THE ATRIAL LEAD WAS UNDER SENSING AND THE OUTPUT WAS HIGH. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252339 CAPSFIX PU SCR.-IN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR 6947 IMPLANTABLE TACHY LEAD