BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3920946 · Received July 8, 2014

    Report

    Report Number
    2938836-2014-13310
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    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 DEVICE REMAINS IMPLANTED. PATIENT WAS FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398473 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3267-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention 7122Q/BKC035312,5076/PJN1174918,1458Q/BPU046779