BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 1954812 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00498
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 27, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE DEVICE'S FUNCTIONALITY WAS TESTED ON THE AUTOMATED ELECTRICAL TEST SYSTEM. THE DEVICE PASSED ALL TESTS. NO ANOMALIES WERE OBSERVED. IT IS BELIEVED THAT LEAD DAMAGE WAS THE CAUSE FOR THE ANOMALY OBSERVED IN THE FIELD. THE LEAD WAS CAPPED AND NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE AND HIGH IMPEDANCE WERE OBSERVED POST DFTS AFTER THE POCKET WAS CLOSED. THE DEVICE WAS EXPLANTED AND REPLACED.

    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 53 YR Required Intervention 1559/65, (B)(4)