BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URCHIN HEART POSITIONER

    MDR report key: 479421 · Received August 19, 2003

    Report

    Report Number
    2135394-2003-00003
    Event Type
    Injury
    Date Received
    August 19, 2003
    Date of Event
    July 9, 2003
    Report Date
    July 25, 2003
    Manufacturer
    MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
    Product Code
    DWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT DURING USE OF THE HEART POSITIONER DEVICE, A NON-MEDTRONIC VACUUM REGULATOR ACCESSORY UNIT UNEXPECTEDLY INCREASED VACUUM-PRESSURE WITHIN THE CIRCUIT TO LEVELS HIGH ENOUGH TO CAUSE PT CARDIAC TISSUE DAMAGE. THE TEAR CAUSED BY THE VACUUM REGULATOR MALFUNCTION WAS REPAIRED INTRAOPERATIVELY WITH NO ADDITIONAL CONSEQUENCE TO THE PT.

    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 Required Intervention