BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL DR

    MDR report key: 1222987 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03246
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 15, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRELIMINARY AND ADDITIONAL ANALYSIS TESTING HIGH CURRENT DRAIN WAS OBSERVED. AFTER THE PULSE GENERATOR WAS CUT OPEN, THE HIGH CURRENT DRAIN COULD NOT BE REPRODUCED. FURTHER TESTING WAS TERMINATED AFTER MORE THAN A MONTH OF TRYING TO REPRODUCE THE HIGH CURRENT DRAIN.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED STEADILY INCREASING CURRENT DRAIN, AND LOW OUTPUTS. THE DEVICE WAS REPLACED, DUE TO INAPPROPRIATELY HIGH CURRENT DRAIN.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-00848. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, DEVICE ENTANGLEMENT LEADING TO FLUSH ISSUES WERE ENCOUNTERED. THE FLOPPY ROTAWIRE BECAME ENTANGLED WITH THE ROTALINK PLUS 1.5MM BURR. THIS ENTANGLEMENT CAUSED BLOCKAGE OF THE BURR ANNULUS AND RESTRICTED THE FLUSH TO THE DISTAL TIP OF THE BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES, AND NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS WAS REPORTED AS 'GOOD'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5826 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention