BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 2083771 · Received May 10, 2011

    Report

    Report Number
    2017865-2011-02960
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    February 21, 2011
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THAT THE PROXIMAL COIL WAS FRACTURED AND THE DISTAL INSULATION WAS DAMAGED AT 33.5 CM FROM THE CONNECTOR PIN. THE DAMAGE TO THE PROXIMAL COIL RESULTED IN A HIGH LEAD IMPEDANCE. THE DAMAGE SUSTAINED WAS A RESULT OF PHYSIOLOGICAL FACTORS (I.E.: RIB-CLAVICLE CRUSH).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT PRESENTED TO THE EMERGENCY ROOM EXPERIENCING SYNCOPE. THE LEAD EXHIBITED IMPEDANCE GREATER THAN 2000 OHMS. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1948/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention