BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3781735 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10095
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    February 18, 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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.THE REPORTED FIELD EVENT OF DIFFICULTY LOOSENING THE SVC SET SCREW WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO SILICONE DEBRIS INSIDE THE SET SCREW HEX CAVITY. THIS MATERIAL PREVENTED LOOSENING OF THE SCREWS IN THE HEX CAVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT DUE TO NORMAL ERI, UNABLE TO REMOVE SVC COIL FROM THE HEADER. THE SET SCREW COULD NOT BE LOOSENED. THE LEAD WAS CAPPED AND THE DEVICE WAS EXPLANTED AND REPLACED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260107 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD 3213-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1