BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL OCL-028-SF

    MDR report key: 277226 · Received May 11, 2000

    Report

    Report Number
    9612007-2000-00012
    Event Type
    Injury
    Date Received
    May 11, 2000
    Date of Event
    September 21, 1999
    Report Date
    April 18, 2000
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS SA
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS DISCHARGED POST STARFLEX IMPLANT WITH THE DEVICE IN ITS PROPER PLACE. FOLLOWING A SESSION OF SWIMMING AND DIVING, THE PT COMPLAINED OF FEVER, STOMACH PAIN, AND LOSS OF BLOOD PER RECTUM. THE PT WAS EVALUATED. THE DEVICE HAD DISLODGED TO THE AORTA. THE PT WAS TAKEN TO THE CATH LAB FOR DEVICE REMOVAL. DURING REMOVAL, THE DEVICE GOT CAUGHT IN THE FEMORAL VEIN. THIS REQUIRED A SURGICAL CUTDOWN AND SUBSEQUENT VENOUS REPAIR. THE PT HAS RECOVERED FROM THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL OCL-028-SF SEPTAL OCCLUDER MLV NMT NEUROSCIENCES IMPLANTS SA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention