BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, DF4 CONNECTOR

    MDR report key: 3890415 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03539
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 12, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THE REPORTED FIELD EVENT OF A SENSING ANOMALY COULD NOT BE CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT NO ANOMALIES WERE FOUND. THE CAUSE OF THE FIELD EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SENSING ANOMALY WAS OBSERVED. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28209 FORTIFY VR, DF4 CONNECTOR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD1231-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 7120Q/52 BJN018361