BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA DR CRT-D

    MDR report key: 4021782 · Received August 19, 2014

    Report

    Report Number
    2938836-2014-14551
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    June 26, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 HAD BEGUN TO ERODE THROUGH THE PATIENTS SKIN, ALTHOUGH THE DEVICE WAS NOT VISIBLE. IT APPEARED THAT THE PATIENT HAD AN OPEN WOUND OVER THE DEVICE. THE PHYSICIAN DID NOT BELIEVE INFECTION CONTRIBUTED TO THE EROSION. THE POCKET WAS REVISED WITH NO COMPLICATIONS. THE PATIENT WILL BE CLOSELY MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498249 QUADRA ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention