BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE ACCEL CRT-D

    MDR report key: 2243120 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06577
    Event Type
    Injury
    Date Received
    September 11, 2011
    Date of Event
    June 21, 2011
    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. OTHER TEXT: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED IMPEDANCE MEASUREMENT ANOMALY WAS CONFIRMED IN THE LABORATORY. THE TEST CODE WAS DOWNLOADED AND THE DEVICE PERFORMED NORMALLY. NO ANOMALY WAS FOUND. THE CAUSE OF THE IMPEDANCE ANOMALY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT, HVLI COULD NOT BE MEASURED. POCKET WAS CLOSED. AGAIN, HVLI COULD NOT BE MEASURED. THE POCKET WAS RE-OPENED AND DEVICE WAS REPLACED. POST-EXPLANT INSPECTION FOUND THAT MORE THAN ONE OF THE LEAD PORTS WERE CLOUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE ACCEL CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3215-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention