BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX LEAD

    MDR report key: 1896294 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05189
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    July 14, 2010
    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 LEAD DISLODGED DUE TO MISSING TINES. THREE OF THE FOUR TINES WERE MISSING, MOST LIKELY DUE TO DAMAGE CAUSED BY AN INTRODUCER OR ANOTHER DEVICE. THERE WAS NO INDICATION THAT THE DAMAGES WERE PRODUCTION RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED.

    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 Required Intervention