BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 3854612 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11469
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 8, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 FIELD EVENT OF A CONNECTOR ANOMALY WAS NOT REPRODUCED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND TEST LEADS WERE INSERTED AND ALL SET SCREWS WERE PROPERLY TIGHTENED. THE CAUSE OF THE CONNECTOR ANOMALY REMAINS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ATRIAL LEAD REVISION, NEITHER THE NEW LEAD OR THE OLD LEAD COULD BE CONNECTED TO THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332347 PROMOTE PLUS CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1