BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE ACCEL CRT-D, DF-4 CONNECTOR

    MDR report key: 3884736 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12090
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 25, 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 Location
    CA
    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 ANOMALOUS MATERIAL WAS CONFIRMED IN THE LABORATORY. VISUAL INSPECTION NOTED DISCOLORATION ON THE HEADER; FURTHER EVALUATION INDICATED THE PRESENCE OF IRON. THE SOURCE OF THE IRON COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING NORMAL DEVICE CHANGE-OUT, RUST WAS OBSERVED IN THE LEAD PORT OF THE DEVICE HEADER. THE PATIENT WAS WELL FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361366 PROMOTE ACCEL CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3215-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR