BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3210651 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03290
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 12, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENTS OF NOISE AND HIGH IMPEDANCE MEASUREMENTS ON THE ATRIAL CHANNEL WERE CONFIRMED VIA REVIEW OF PROGRAMMER PRINTOUTS. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE FOUND. THE HIGH IMPEDANCE MEASUREMENTS WERE BELIEVED TO HAVE BEEN CAUSED BY AN INTERMITTENT ISSUE THAT WAS NOT CAUSED BY A DEVICE MALFUNCTION. THE ROOT CAUSE OF THE NOISE COULD NOT BE DETERMINED BECAUSE THE NOISE COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING DEVICE EXPLANT PROCEDURE LOSS OF CAPTURE FROM THE ATRIAL LEAD WAS DISCOVERED ALONG WITH LEAD IMPEDANCE MEASUREMENT CHANGE AND SENSING ISSUES. THE PATIENT RECENTLY UNDERWENT SURGERY AND RADIATION THERAPY IN THE SAME AREA OF THE DEVICE. AFTER FURTHER TESTING, ALL MEASUREMENT WENT BACK TO NORMAL. THE DEVICE WAS REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309237 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 71 YR