BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 3923506 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14782
    Event Type
    Injury
    Date Received
    July 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP, THE ATRIAL LEAD EXHIBITED LOSS OF SENSING AND CAPTURE AND THE IMPEDANCE WAS OUT OF RANGE. A CHEST X-RAY REVEALED THAT THE LEAD HAD DISLODGED. THE LEAD WAS SUCCESSFULLY REPOSITIONED; THE ELECTRICAL VALUES RESUMED NORMAL FUNCTION. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE AND WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400124 OPTISENSE PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1999/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention