BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 4220941 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17380
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 26, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED CONNECTOR ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. TEST LEADS WERE ABLE TO INSERT NORMALLY INTO THE HEADER AND THE LEAD PORT DIAMETERS WERE FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT FOR ERI, THE PACE/SENSE OF THE RV LEAD COULD NOT BE FULLY REMOVED FROM THE DEVICE HEADER. SET SCREWS WERE FULLY REMOVED, BUT THE PIN REMAINED STUCK IN THE HEADER. AFTER CUTTING THE RV LEAD, THE DEVICE WAS SUCCESSFULLY EXPLANTED. PATIENT DID NOT EXPERIENCE ADVERSE CONSEQUENCES AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703530 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR