BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 2242956 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06568
    Event Type
    Malfunction
    Date Received
    September 11, 2011
    Date of Event
    July 19, 2011
    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. ANALYSIS OF THE DEVICE FOUND AN ANOMALY DURING HV AUTOMATED TESTING. THE DEVICE BECAME DAMAGED AND NO FURTHER TESTING COULD BE PERFORMED. (B)(4); NO COMPLAINT RECEIVED WITH RETURN OF DEVICE; FAILURE (EVENT) OBSERVED DURING ANALYSIS.

    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 FORTIFY DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1