BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSIVE PLUS DX

    MDR report key: 1955602 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00681
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    October 20, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960030
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIPOLAR VENTRICULAR IMPEDANCE WAS 1700 OHMS. THE RIGHT VENTRICULAR CAPTURE THRESHOLD INCREASED FROM 0.5 V, 0.5 MS TO 5.0 V, 0.5 MS AND SENSING DECREASED FROM 12 MV TO 5.9 MV. THE RIGHT VENTRICULAR POLARITY WAS CHANGED TO UNIPOLAR AT MAXIMUM OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSIVE PLUS DX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1346T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR