BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE PLUS CRT-D, DF-4 CONNECTOR

    MDR report key: 1954749 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00511
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    October 8, 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. RELIABILITY LABORATORY TECHNICIAN; (B)(4) FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS FOUND INTERMITTENT HIGH VOLTAGE CHARGING CAPABILITY IN THE DEVICE DUE TO AN ANOMALOUS HIGH VOLTAGE CAPACITOR.

    Description of Event or Problem · 1

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

    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