BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3143138 · Received May 30, 2013

    Report

    Report Number
    2916596-2013-00682
    Event Type
    Death
    Date Received
    May 30, 2013
    Date of Event
    May 24, 2011
    Report Date
    May 3, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WAS ADVISED THAT THE EXPLANTED LVAD PUMP WILL NOT BE RETURNING FOR EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED. THE ATTACHED USER FACILITY REPORT (B)(4) WAS RECEIVED FROM THE (B)(6) REGISTRY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR RECEIVED AN INTERMACS REPORT WHICH STATED THAT THE PT WAS FOUND EXPIRED WITH BOTH POWER LEADS DISCONNECTED, LYING IN HER BED. ADD'L INFO WAS RECEIVED BY THE VAD COORDINATOR STATING THAT THE LVAD PUMP WAS NOT EXPLANTED AND AN AUTOPSY WAS NOT DONE. THE ATTACHED USER FACILITY REPORT (B)(4) WAS RECEIVED FROM THE (B)(6) REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238671 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 97843

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death