BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX S

    MDR report key: 1223847 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03441
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 11, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPLACEMENT OF THE VENTRICULAR LEAD, BLOOD WAS NOTED WITHIN THE INSULATION AT THE PROXIMAL PORTION OF THE ATRIAL LEAD. THE LEAD WAS EXPLANTED, AND INSULATION DAMAGE WAS NOTED 10 TO 15 CM FROM THE DISTAL TIP.

    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