BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX S

    MDR report key: 1223928 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03377
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    April 4, 2008
    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

    THE REPORTED EXIT BLOCK WAS MOST LIKELY DUE TO INSUFFICIENT CONTACT CAUSED BY MISSING TINES. IT IS LIKELY THAT AN INTRODUCER OR ANOTHER DEVICE INDUCED THE FAILURE AND OVER TIME THE DAMAGE TO THE TINES PROPAGATED AND FINALLY FRACTURE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED EXIT BLOCK AND UNDERSENSING. DURING REPOSITIONING THE LEAD WAS FOUND TO BE MISSING TINES. THE LEAD WAS EXPLANTED AND REPLACED.

    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 1646T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention