BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 2905407 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00737
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 4, 2012
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE PRE-DISCHARGE FOLLOW UP THE LEAD EXHIBITED IMPEDANCE OF 2000 OHMS. A CHEST X-RAY REVEALED THAT THE LEAD HAD DISLODGED AND WAS REPOSITIONED. AT A F/U ON 10/05 THE LEAD EXHIBITED IMPEDANCE OF 3000 OHMS. THE PHYSICIAN DECIDED TO REPOSITION THE LEAD. DURING THE REPOSITIONING THE PHYSICIAN NOTED THAT THE LEAD WAS NOT SECURED TO THE HEADER. THE PHYSICIAN BELIEVED THIS WAS DONE DURING THE PREVIOUS REPOSITION. THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12747 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