BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3914600 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13177
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 LEADS AND DEVICE WERE PROMINENT AND SUPERFICIAL ON THE SKIN. THE POCKET WAS REVISED AND THE DEVICE WAS IMPLANTED SUBPECTORALLY FROM A SUBCUTANEOUS POSITION. THE LEAD REMAINS IMPLANTED. PATIENT WAS FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390550 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention (B)(4)