BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D, DF-4 CONNECTOR

    MDR report key: 1831103 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03607
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 16, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 IMPEDANCE ANOMALY WAS VERIFIED VIA REVIEW OF THE DEVICE'S DIAGNOSTICS DATA. THE DEVICE'S ELECTRONIC CIRCUITRY WAS TESTED BOTH MANUALLY ON THE BENCH AND USING OUR AUTOMATED ELECTRICAL TESTING SYSTEM. ALL FUNCTIONAL MEASUREMENTS WERE NORMAL. NO ANOMALY WAS DETECTED. THE CAUSE OF THE REPORTED IMPEDANCE MEASUREMENT ANOMALY REMAINS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE WAS OBSERVED. IT WAS UNABLE TO DETERMINE IF THE ANOMALY WAS FROM THE DEVICE OR THE LEAD. HENCE, THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE PLUS CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 7121Q/58 (B)(4)