BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT PLUS DR

    MDR report key: 3210417 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03369
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 18, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT OF A LEAD IMPEDANCE MEASUREMENT AND SENSING ANOMALY WERE CONFIRMED IN THE LABORATORY. ANALYSIS FOUND THAT THE ATRIUM RING SET SCREW HAD SEPTUM DEBRIS IN THE CAVITY, WHICH PREVENTED PROPER INSERTION OF THE SCREW DRIVER AND INADEQUATE ELECTRICAL CONTACT BETWEEN THE DEVICE AND THE LEAD. THIS CAUSED BOTH THE HIGH ATRIAL PACING LEAD IMPEDANCE AND LOW SENSING OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT, THE PHYSICIAN INITIALLY HAD DIFFICULTY TIGHTENING THE SET SCREWS IN THE ATRIAL PORT. HIGH LEAD IMPEDANCE AND POOR SENSING WERE OBSERVED ON THE ATRIAL LEAD. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310187 CURRENT PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1