BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3220282 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04237
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    April 23, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT FOR LOW IMPEDANCE ON THE LV LEAD WAS RECEIVED VIA TRANSMISSION. IT WAS RECOMMENDED TO HAVE PATIENT FOLLOW UP IN CLINIC ALONG WITH POSSIBLE PROGRAMMING CHANGES. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319459 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 1156T/75, AGU20619