BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE FIXATION ENDOCARDIAL LEAD

    MDR report key: 1223844 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03438
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 25, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 VENTRICULAR IMPEDANCE HAD RISEN SHARPLY FROM A YEAR AGO. THE BIPOLAR IMPEDANCE ROSE FROM 666 OHMS TO 1448 OHMS, AND THE UNIPOLAR IMPEDANCE WAS1353 OHMS. CAPTURE THRESHOLDS HAD ALSO INCREASED AND WERE GREATER THAN 5 V.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVE FIXATION ENDOCARDIAL LEAD PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1188T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1