BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT PLUS DR, DF-4 CONNECTOR

    MDR report key: 1955231 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00481
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 24, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    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) - OBSERVED DURING ANALYSIS. ANALYSIS REVEALED THAT THE DEVICE'S RF MODULE WAS FOUND TO BE ANOMALOUS.

    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 CURRENT PLUS DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1