BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR, DF-4 CONNECTOR

    MDR report key: 4334462 · Received December 16, 2014

    Report

    Report Number
    2938836-2014-18744
    Event Type
    Injury
    Date Received
    December 16, 2014
    Date of Event
    October 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED HIGH PACING LEAD IMPEDANCE WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE PROGRAMMER PRINTOUTS; THE REPORTED LOOSE CONNECTION WAS BELIEVED TO BE THE CAUSE. VISUAL INSPECTION NOTED SEPTUM MATERIAL PRESENT IN THE V DF-4 SET SCREW HEX CAVITY AND THE SETSCREW STRIPPED. WHEN THE SETSCREW ANOMALY OCCURRED COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING A VIBRATORY ALERT, THE DEVICE EXHIBITED HIGH, OUT OF RANGE PACING LEAD IMPEDANCE ON THE RIGHT VENTRICULAR CHANNEL. POCKET MANIPULATION PRODUCED NOISE AND LOSS OF SENSING. THE POCKET WAS OPENED AND THE LEAD WAS ABLE TO BE PULLED OUT OF THE CONNECTOR WITHOUT LOOSENING THE SETSCREW. THE LEAD TESTED NORMAL THROUGH THE ANALYZER AND WHEN RECONNECTED TO THE DEVICE. A SETSCREW ISSUE WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THERE WAS NO SUSPICION OF AN ISSUE WITH THE SET SCREW. THE LEAD WAS ABLE TO BE EASILY REMOVED FROM THE DEVICE BECAUSE THE IMPLANTING PHYSICIAN HAD FORGOTTEN TO TIGHTEN THE SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822857 FORTIFY ASSURA VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1357-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention