BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 2905123 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00726
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 22, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND CLAVICLE CRUSH FRACTURE ON THE PROXIMAL COILS AT 19.2 CM FROM THE CONNECTOR PIN; THE FRACTURE LED TO THE REPORTED HIGH LEAD IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICLE LEAD EXHIBITED HIGH LEAD IMPEDANCE; THE IMPEDANCE IN BIPOLAR CONFIGURATION WAS GREATER THAN 2000 OHMS. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11846 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1948/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention