BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR, DF4 CONNECTOR

    MDR report key: 2984418 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00540
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 24, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    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)(6). NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS FOUND HIGH VOLTAGE OUTPUT CIRCUIT DAMAGE ON THE DEVICE. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. THE LOW VOLTAGE FUNCTIONALITY WAS TESTED ON THE BENCH AND OUR AUTOMATED TESTING EQUIPMENT. ALL OF THE LOW VOLTAGE TEST SPECIFICATIONS WERE NORMAL.

    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
    88307 FORTIFY DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2233-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1