BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP CRT-D, DF-4 CONNECTOR

    MDR report key: 3901046 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12597
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 THE DEVICE WAS FOUND TO BE FLIPPED OVER IN THE POCKET. THE DEVICE WAS REPOSITIONED TO SUBMUSCULAR POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380104 QUADRA ASSURA MP CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3371-40Q NA

    Patients

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