BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 2240189 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05773
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    June 29, 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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    SHOULD HAVE BEEN (B)(4) 2011, INSTEAD OF (B)(4) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AT 7.5 V, 1.5 MS DUE TO LEAD DISLODGEMENT. ATTEMPTS TO REPOSITION THE LEAD FAILED. THE LEAD WAS REMOVED. THREE OF THE TINES ON THE LEAD TIP WERE MISSING AFTER REMOVAL. THE LEAD WAS 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 (B)(4)