BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 4081393 · Received January 14, 2014

    Report

    Report Number
    2938836-2014-06143
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    May 7, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW LV LEAD IMPEDANCE WAS OBSERVED THE PATIENT NOTIFIER TRIGGERED. PATIENT WILL BE BROUGHT TO CLINIC TO PERFORM ISOMETRICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34830 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK NIK ST. JUDE MEDICAL INC., CRMD 3207-36

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR