BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX S

    MDR report key: 1073303 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-01967
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    March 3, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 FOUR DAYS POST IMPLANT, THE ATRIAL LEAD DISLODGED. THE LEAD WAS REPOSITIONED. THE PATIENT PRESENTED WITH SICK SINUS SYNDROME AND WAS NOT PACEMAKER DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX S PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1642T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention