BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSIVE PLUS

    MDR report key: 1050524 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01500
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    March 1, 2008
    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
    MA
    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 LESS THAN 200 OHMS IMPEDANCE IN BOTH CONFIGURATIONS. BIPOLAR SENSING THRESHOLDS WERE AT 3.2 MV. THE LEAD WOULD BE MONITORED THROUGH CLINICAL FOLLOW-UPS.

    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 1246T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1