BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX LEAD

    MDR report key: 1955646 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-01002
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 15, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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 ATRIAL LEAD EXHIBITED NOISE THAT COULD BE SEEN ON THE STORED ELECTROGRAMS. IT WAS ALSO NOTED THAT THERE WERE MANY INAPPROPRIATE AUTOMATIC MODE SWITCH EPISODES. THE NOISE COULD BE REPRODUCED WITH POCKET MANIPULATION AND ISOMETRICS. PROGRAMMING WAS SET TO DDI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX LEAD PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1944/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR