BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT

    MDR report key: 8842495 · Received July 24, 2019

    Report

    Report Number
    8842495
    Event Type
    Death
    Date Received
    July 24, 2019
    Date of Event
    July 18, 2019
    Report Date
    July 23, 2019
    Manufacturer
    ABBOTT
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HM3 IMPLANT (B)(6) 2019 AND ASCENDING AORTA REPLACEMENT. PT WAS TAKEN BACK TO THE OPERATING ROOM FOR BLEEDING LATER THAT EVENING. THE FOLLOWING DAY, HE WAS WOKEN UP AND FOLLOWED ALL COMMANDS PRIOR TO EXTUBATION. AFTER EXTUBATION, HE HAD A SUDDEN CHANGE IN NEURO STATUS. PT WAS REINTUBATED AND TAKEN TO CT SCAN. ALTHOUGH NOTHING WAS SEEN INITIALLY ON SCANS, SUBSEQUENT SCANS SHOWED INFARCT IN THE RIGHT CEREBELLAR HEMISPHERES, RIGHT TEMPORAL LOBE AS WELL AS A RIGHT PARIETOOCCIPITAL REGION. THIS RESULTED IN LEFT SIDED HEMIPARESIS. NEUROLOGY ADVISED TO RESTART ANTICOAGULATION AND FOLLOW CT SCANS. PT WAS EXTUBATED AGAIN (B)(6) 2019 AND UNFORTUNATELY WAS REINTUBATED (B)(6) 2019. RECOMMENDATION WAS FOR TRACH AND G-TUBE PLACEMENT ON (B)(6) 2019, HOWEVER, THE PT'S FAMILY DECIDED THAT THE PT WOULD NOT WANT TO HAVE THOSE PROCEDURES DONE. THE PT'S FAMILY ASKED TO WITHDRAW CARE AND MAKE THE PT COMFORTABLE ON (B)(6) 2019. FENTANYL AND ATIVAN WERE GIVEN. LEVOPHED WAS STOPPED. PT WAS EXTUBATED AND THE VAD ARE STOPPED. THE PT EXPIRED AT 12:26 PM ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618628 ABBOTT HEARTMATE 3 DSQ ABBOTT 106523US

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death