BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URCHIN HEART POSITIONER

    MDR report key: 525180 · Received February 6, 2004

    Report

    Report Number
    2135394-2004-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2004
    Date of Event
    January 7, 2004
    Report Date
    January 7, 2004
    Manufacturer
    MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE UNIT DID NOT CAPTURE (HOLD) THE HEART DURING THE PROCEDURE, ALTHOUGH THE APPLIED VACUUM APPEARED ADEQUATE. PATIENT'S CARDIAC TISSUE WAS DEEMED TO BE FRAGILE DURING PRE-OPERATIVE ASSESSMENT. A TEAR WAS NOTED IN THE EPICARDIUM DURING THE CASE, BUT HE HCP INDICATED NO SURGICAL INTERVENTION OCCURRED. THE DEVICE WAS REMOVED AND THE CASE COMPLETED WITH NO POST-OPERATIVE COMPLICATIONS REPORTED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URCHIN HEART POSITIONER HEART POSITIONER DWS MEDTRONIC CARDIAC SURGERY TECHNOLOGIES 29700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other