BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3914544 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13121
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    April 1, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HIGH VOLTAGE LEAD IMPEDANCE HAVE BEEN SLOWLY INCREASING. IT WAS UNABLE TO DETERMINE THE CAUSE OF THE IMPEDANCE ANOMALY AND FURTHER LEAD EVALUATION WAS RECOMMENDED. THE DECISION WAS MADE TO CONTINUE MONITORING THE PATIENT. NO CHANGES WILL BE MADE UNTIL THE BATTERY REACHES ERI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389672 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 1591/65, CU12702