BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 3923463 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14748
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION INCLUDED. FINAL ANALYSIS FOUND A PARTIAL LEAD WAS RECEIVED IN TWO PIECES. INSULATIONS NOTED AT 70.2 CM TO 70.5 CM FROM THE DISTAL TIP WAS CAUSED BY FRICTION TO ANOTHER IMPLANTABLE DEVICE. THIS COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT OF NOISE PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICLE LEAD EXHIBITED NOISE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399488 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1948/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention PM2210, 7106380