BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2800355 · Received October 16, 2012

    Report

    Report Number
    2916596-2012-00950
    Event Type
    Death
    Date Received
    October 16, 2012
    Date of Event
    August 27, 2012
    Report Date
    September 20, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT EXPIRED AND NO AUTOPSY WAS PERFORMED. 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

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT HAD COMPLICATIONS FROM PERITONITIS. THE PT HAD MANY POST-OPERATION COMPLICATIONS INCLUDING PULMONARY HTN, PERFORATED COLON AND SEPSIS. THE PT NEVER RECOVERED AFTER DEVICE IMPLANT AND EXPIRED. THERE WERE NO ALARMS AND NO AUTOPSY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 111557

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death