BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VE LVAS (TCI HEARTMATE)

    MDR report key: 250036 · Received November 17, 1999

    Report

    Report Number
    250036
    Event Type
    Injury
    Date Received
    November 17, 1999
    Date of Event
    September 24, 1999
    Report Date
    October 23, 1999
    Manufacturer
    THERMO CARDIOSYSTEMS, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD HEART PUMP IMPLANTED IN 1998 AS A BRIDGE TO TRANSPLANTATION. IN 1999, PT EXPERIENCED DEVICE MALFUNCTION. MFR WAS SENT WAVEFORM ANALYSIS AND WAS UNABLE TO IDENTIFY DEFECT. SITE VISIT DONE BY TCI CLINICAL APPLICATIONS SPECIALIST WHO WAS UNABLE TO REPLICATE THE MALFUNCTION. MAXIMUM PUMP RATE/FLOWS STILL NOT IDENTIFIED. PT UNDERWENT HEART TRANSPLANTATION IN 1999. PUMP AND DRIVELINE SENT TO MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VE LVAS (TCI HEARTMATE) Implant HEARTMATE DSQ THERMO CARDIOSYSTEMS, INC. 1212 82530026

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization