BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSIVE PLUS

    MDR report key: 1073419 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02203
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    May 27, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE INTERROGATION REVEALED NON CAPTURE AT 6.5 V, 1.0 MS WITH ADEQUATE BIPOLAR SENSING. THE PULSE GENERATOR WAS PROGRAMMED TO VDD MODE DUE TO ADEQUATE ATRIAL SENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSIVE PLUS PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1342T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1