BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 3926094 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15435
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    P960030
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    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 DURING ROUTINE FOLLOW UP, THE ATRIAL LEAD EXHIBITED HIGH THRESHOLDS. CHEST X-RAY CONFIRMED THE LEAD HAD DISLODGED. THE LEAD WAS SUCCESSFULLY REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402809 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1944/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention