BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3903734 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12859
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 21, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP, HIGH, OUT OF RANGE PACING LEAD IMPEDANCE AND AN INCREASE IN CAPTURE THRESHOLD WERE OBSERVED ON THE RV LEAD. THE CHANGES CORRESPONDED WITH RADIATION TREATMENT. A FLUOROSCOPY DID NOT REVEAL ANY VISUAL DEFECTS ON THE LEAD. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381258 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7121/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention