BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6142329 · Received December 2, 2016

    Report

    Report Number
    2916596-2016-02329
    Event Type
    Death
    Date Received
    December 2, 2016
    Date of Event
    October 4, 2016
    Report Date
    November 7, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE UNIQUE IDENTIFIER (UDI) - DEVICE WAS MANUFACTURED PRIOR TO UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE ¿ 4 YEARS AND 6 MONTHS. THE PUMP WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED SUBDURAL HEMATOMA COULD NOT BE CONCLUSIVELY DETERMINED. THE CUSTOMER REPORTED THAT THE PATIENT CABLE BECAME TANGLED IN THE PATIENT¿S WALKER CAUSING THE PATIENT TO TRIP, FALL, AND SUFFER HEAD TRAUMA. THE PATIENT HAD INITIALLY REFUSED TO GO TO THE EMERGENCY DEPARTMENT; HOWEVER, THE FOLLOWING DAY THE PATIENT WAS UNABLE TO MOVE, AND WAS SUBSEQUENTLY TAKEN TO THE HOSPITAL. A SUBDURAL HEMATOMA WAS DIAGNOSED. THE PATIENT SUBSEQUENTLY DETERIORATED AND EXPIRED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2012. IT WAS REPORTED THAT ON (B)(6) 2016, WHILE THE PATIENT WAS AT HOME AMBULATING TO THE BATHROOM, THE PATIENT CABLE BECAME TANGLED IN THE PATIENT¿S WALKER CAUSING THE PATIENT TO TRIP, FALL, AND SUFFER HEAD TRAUMA. THE PATIENT HAD INITIALLY REFUSED TO GO TO THE EMERGENCY DEPARTMENT; HOWEVER, THE FOLLOWING DAY THE PATIENT WAS UNABLE TO MOVE, AND WAS SUBSEQUENTLY TAKEN TO THE HOSPITAL. A SUBDURAL HEMATOMA WAS DIAGNOSED. THE PATIENT SUBSEQUENTLY DETERIORATED AND EXPIRED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792611 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death