BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 1955644 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-01018
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    October 22, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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 THE VENTRICULAR LEAD WAS UNDERSENSING THE VENTRICLE, BUT PICKING UP ATRIAL PACING. A CHEST X-RAY WAS PERFORMED, REVEALING THAT THE LEAD HAD PULLED BACK UP NEAR THE TRICUSPID AREA AND THAT THE LEAD PIN WAS NOT COMPLETELY INSERTED INTO THE PULSE GENERATOR HEADER.

    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 69 YR