BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 1223067 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03771
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 26, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF NOISE ON THE ATRIAL CHANNEL WAS CONFIRMED VIA REVIEW OF STORED EGMS. TEST LEADS WERE CONNECTED TO THE DEVICE AND ALL OF THE SETSCREW S WERE ABLE TO SECURE, EXCEPT FOR THE ATIP SETSCREW. THE ATIP SETSCREW WAS FOUND TO BE STRIPPED AND CONTAINED SEPTUM MATERIAL INSIDE OF THE HEX CAVITY. WITH THE TEST LEADS CONNECTED, THE DEVICE HEADER WAS MANIPULATED AND NOISE WAS OBSERVED ON THE ATRIAL L CHANNEL AND RESEMBLED WHAT WAS RECORDED ON THE STORED EGMS. IT IS BELIEVED THAT THE NOISE OBSERVED IN THE FIELD WAS DUE TO THE ATIP SETSCREW.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    NOISE WAS OBSERVED ON A REAL-TIME ATRIAL EGM. NOISE WAS VISUALIZED DURING ISOMETRICS AND AT REST. THE PACING LEAD IMPEDANCE HAD ALSO INCREASED. A LOOSE SETSCREW WAS SUSPECTED. AFTER CHECKING THE DEVICE, THE SETSCREW IN THE RING WAS FOUND TO BE STRIPPED. HENCE, THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention