BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2935868 · Received January 22, 2013

    Report

    Report Number
    2916596-2013-00101
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    June 25, 2009
    Report Date
    December 4, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO REPLACE DUPLICATE MDR NUMBER (B)(4). THE ATTACHED USER FACILITY REPORT WAS RECEIVED FROM THE (B)(4) REGISTRY. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    A (B)(4) REPORT WAS RECEIVED WHICH STATED: "INFLOW GRAFT MALFUNCTION/MALPOSITION" AND "INFLOW CANNULA OBSTRUCTION PREVENTING BLOOD FLOW".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31587 HEARTMATE LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1270 64102

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention