BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 3914533 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13140
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF A CONNECTOR ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND TEST LEADS WERE INSERTED WITH NO ANOMALIES. THE CAUSE OF THE FIELD EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE ATRIAL LEAD COULD NOT BE FULLY INSERTED INTO THE HEADER PORT. DEVICE WAS NOT IMPLANTED. PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389705 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2377-36QC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR