BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSIVE PLUS

    MDR report key: 1050583 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01285
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    August 1, 2007
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED GREATER THAN 2500 OHMS IMPEDANCE IN BOTH CONFIGURATIONS. POOR SENSING AND NO CAPTURE WERE ALSO NOTED.

    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/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1