BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX S, FGI

    MDR report key: 609778 · Received January 10, 2005

    Report

    Report Number
    2017865-2005-00047
    Event Type
    Injury
    Date Received
    January 10, 2005
    Date of Event
    September 8, 2004
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED REGARDING THE EXPLANTED DEVICE DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES LEAD DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX S, FGI PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1642T/40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention