BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3842648 · Received May 16, 2014

    Report

    Report Number
    2916596-2014-00774
    Event Type
    Death
    Date Received
    May 16, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 18, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF LOW VOLTAGE AND LOW BATTERY ALARMS, AND THE LOSS OF POWER WAS CONFIRMED BASED ON THE EVALUATION OF LOG FILE RETRIEVED FROM THE RETURNED HEARTMATE II SYSTEM CONTROLLER; HOWEVER, A SPECIFIC CAUSE FOR THE EVENTS AND A CORRELATION TO THE REPORTED HEAD INJURY COULD NOT BE CONCLUSIVELY DETERMINED. THE EVENTS CAPTURED IN THE LOG FILE APPEARED TO SHOW THE PUMP OPERATING NORMALLY AT THE SET SPEED OF 9400 RPM PRIOR TO THE LOW VOLTAGE AND LOW BATTERY ALARMS, AND LOSS OF POWER EVENT. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE HOSPITAL REPORTED THAT THE LVAD PUMP WAS NOT EXPLANTED. 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 (LVAD). IT WAS REPORTED THAT THE POLICE FOUND THE PATIENT UNCONSCIOUS AT HOME ALONE. THE PATIENT HAD AN APPARENT HEAD INJURY AND THE LVAD WAS NOT ALARMING WHEN THE POLICE ARRIVED. THE VAD TEAM CHECKED THE SYSTEM CONTROLLER WHICH REVEALED A LOW VOLTAGE ALARM. IN THE E.R., THE PATIENT WAS GIVEN EPINEPHRINE AND GOT A PULSE AND BLOOD PRESSURE. THE NEUROLOGIST DETERMINED THAT THE BLEED TO HEAD WAS OF UNKNOWN CAUSE. THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293146 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114087

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death