BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4222482 · Received October 31, 2014

    Report

    Report Number
    2916596-2014-01997
    Event Type
    Death
    Date Received
    October 31, 2014
    Date of Event
    July 18, 2014
    Report Date
    October 2, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO THE MFR FOR EVALUATION, AS IT WAS NOT EXPLANTED. 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 (LVAD). IT WAS REPORTED TO THE MFR THROUGH THE DEVICE TRACKING FORM FROM THE HOSPITAL THAT THE PT EXPIRED ON (B)(6) 2014. THE CAUSE OF EXPIRATION WAS NOTED AS "NEURO". ADDITIONAL INFO WAS RECEIVED FROM THE VAD COORDINATOR THAT ON (B)(6) 2014, THE PT EXPERIENCED A SUBACUTE LEFT FRONTAL ISCHEMIC CEREBRAL INFARCT. THE PT'S ANTICOAGULATION MEDICATION WAS HELD DUE TO THE PT HAVING A HISTORY OF GI BLEEDING. THE PT WAS DISCHARGED AND HIS ANTICOAGULATION MEDICATION WAS RESTARTED ON (B)(6) 2014. ON (B)(6) 2014, THE PT WAS ADMITTED INTO THE HOSPITAL FOR RESIDUAL RIGHT HAND WEAKNESS. AT THE TIME THE PT WAS DEEMED INCOMPETENT, AND HE WAS DISCHARGED TO HOME (B)(6) 2014 WITH HOME CARE. ON (B)(6) 2014 HE DEVELOPED A RETROPERITONEAL BLEED, POSSIBLY FROM A FALL AT HOME. HIS ANTICOAGULATION MEDICATION WAS HELD AT THAT TIME AND THE PT WAS ADMITTED INTO A NURSING HOME. THE PT'S HEALTH STATUS DECLINED AND WAS GIVEN COMFORT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698198 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 107494

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death