BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE

    MDR report key: 610052 · Received July 6, 2004

    Report

    Report Number
    2184009-2004-00066
    Event Type
    Malfunction
    Date Received
    July 6, 2004
    Date of Event
    June 11, 2004
    Report Date
    June 14, 2004
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    MNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT DURING THE CASE THE VACUUM RELIEF VALVE LEAKED. THE DEVICE WAS CUT OUT OF THE AORTIC ROOT VENT LINE AND WAS INTRA-OPERATIVELY REPLACED. THE HCP INDICATED THERE WAS NO INTERRUPTION TO BYPASS DURING COMPONENT CHANGE-OUT AND NO CONSEQUENCE WAS REPORTED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE VACUUM RELIEF VALVE MNJ MEDTRONIC PERFUSION SYSTEMS VRV-100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention