BEUDAMED
    FDA Adverse Event Death Summary report: N

    HM II LVAS EUROPE

    MDR report key: 1991220 · Received February 10, 2011

    Report

    Report Number
    2916596-2011-00030
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 12, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 19 MONTHS POST-IMPLANT, THE PATIENT INFORMED THE CLINIC ABOUT A RED HEART ALARM ALONG WITH A CONTINUOUS AUDIBLE ALARMS. THE SYSTEM CONTROLLER IN USE WAS EXCHANGED TO THE BACKUP SYSTEM CONTROLLER; HOWEVER, THERE WAS NO RESOLUTION OF THE ALARMS. THE PATIENT WAS TAKEN TO THE HOSPITAL AND AFTER FURTHER EVALUATION BY THE HOSPITAL STAFF, A DECISION WAS MADE NOT TO PROCEED WITH A PUMP EXCHANGE. THE PATIENT EXPIRED ON 2011-(B)(6). SPECIFIC ACTIONS TAKEN BY THE HOSPITAL STAFF RELEVANT TO THE CARE OF THE PATIENT ARE UNKNOWN; HOWEVER, PHOTOGRAPHS TAKEN OF THE IMPLANTED PUMP AT THE TIME OF EXPLANT REVEALED DAMAGE OF THE INTRACORPOREAL PART OF THE DRIVELINE AT THE PUMP HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HM II LVAS EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 102139

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death