BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3834426 · Received May 6, 2014

    Report

    Report Number
    2916596-2014-00711
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 7, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). INFO WAS PROVIDED TO THE MFR THROUGH THEIR DEVICE TRACKING SYSTEM INDICATING THAT A PUMP EXCHANGE TOOK PLACE ON (B)(6) 2014. THE PRE-OP ECHO REPORT REVEALED A 12 X 10 MM THROMBUS IN THE OUTFLOW CONDUIT. AFTER GOING THROUGH THE PATIENT'S CHART AND LAB HISTORY IT APPEARED THAT THE PT IS SUFFERING FROM SEPTIC SHOCK, ORIGINATING FROM HER AICD, BUT STARTING IN (B)(6) 2013. SHE HAS HAD NUMEROUS SUB THERAPEUTIC INR LAB VALUES. THE PT WAS CURRENTLY VERY UNSTABLE AND ON DIALYSIS. DURING HER CURRENT ADMISSION HER INR RANGED FROM 1.3 TO 8.1, MULTIPLE PI EVENTS DURING DIALYSIS AND POWERS THAT WHILE THEY REMAIN STABLE AT 6-8, HAVE ELEVATED TO 14 INTERMITTENTLY DURING HER HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271035 HEARTMATE II LVAS LEFT VENTRICULAR ASSIS DEVICE DSQ THORATEC CORP. 104911 124664

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention