BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE ACCEL CRT-D

    MDR report key: 1954769 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00517
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 22, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    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. (B)(4). NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS FOUND THE RF MODULE TO HAVE AN ANOMALOUS COMPONENT.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    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