BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2780218 · Received October 5, 2012

    Report

    Report Number
    2916596-2012-00937
    Event Type
    Death
    Date Received
    October 5, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 7, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE IS CURRENTLY NO INFO TO SUSPECT A DEVICE MALFUNCTION, THE MFR IS CONTINUING TO REQUEST ADD'L INFO REGARDING THIS EVENT. 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 ON (B)(6) 2012. SEVERAL HRS AFTER THE SURGERY, THE PT DEVELOPED SEVERE RIGHT VENTRICLE FAILURE AND WAS RETURNED TO THE OPERATING ROOM AND A RIGHT VENTRICULAR ASSIST DEVICE WAS PLACED. DURING THE NEXT SEVERAL DAYS, THE PT DEVELOPED MULTI-SYSTEM ORGAN FAILURE AND A DECISION WAS MADE TO DISCONTINUE PUMP SUPPORT. AFTER TURNING DOWN THE PT'S VADS, THE PT PROMPTLY EXPIRED. THERE WAS NO AUTOPSY PERFORMED. THE PUMP WAS NOT EXPLANTED OR RETURNED TO THE MFR.

    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 CORPORATION 104911 117497

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death