BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL SEPTAL OCCLUDER IMPLANT

    MDR report key: 2364833 · Received January 10, 2006

    Report

    Report Number
    2364833
    Event Type
    Injury
    Date Received
    January 10, 2006
    Date of Event
    December 21, 2005
    Report Date
    January 9, 2006
    Manufacturer
    NMT MEDICAL INC
    Product Code
    MLV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED A CARDIOSEAL PFO OCCLUDER HDE DEVICE FOR A PPO ON (B)(6) 2005. IN THE THIRD MONTH FOLLOW UP ON (B)(6) 2005, IT WAS DETERMINED WITH TRANSTHORACIC ECHOCARDIOGRAM THAT THE DEVICE WAS NOT IN PLACE. PATIENT HAD A FLUOROSCOPY AND TRANS ESOPHAGEAL ECHOCARDIOGRAM PROCEDURES TO CONFIRM THE LECTION OF THE DEVICE ON (B)(6) 2005. THE RESULT SHOWED THAT THE DEVICE WAS IN THE ABDOMINAL AORTA, THEREFORE SUBJECT IMMEDIATELY TRANSFERRED TO THE OPERATING ROOM AND THE DEVICE WAS REMOVED SURGICALLY ON (B)(6) 2005. PATIENT DISCHARGED TO HOME ON (B)(6) 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL SEPTAL OCCLUDER IMPLANT SEPTAL/PFO CLOSURE DEVICE MLV NMT MEDICAL INC NA 0507126

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R