BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3910970 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-12916
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF SET SCREW ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. UPON RECEIPT, THE HEADER WAS NOTED TO BE BROKEN AND NONE OF THE SET SCREWS RETURNED. WITHOUT RETURN OF THE ENTIRE DEVICE, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE REPLACEMENT PROCEDURE, THE ATRIAL LEAD WAS NOT ABLE TO BE REMOVED FROM THE HEADER. THE SET SCREW WAS TIGHT AND WOULD NOT UNSCREW. THE LEAD WAS CAPPED AND A NEW DEVICE WAS IMPLANTED. PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387350 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD 3213-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1