BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DRIVE

    MDR report key: 3960051 · Received July 17, 2014

    Report

    Report Number
    2916596-2014-01096
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A CORRELATION OF THE SUBARACHNOID HEMORRHAGE TO THE DEVICE COULD NOT BE DETERMINED. THE PATIENT REMAINS ONGOING ON PUMP SUPPORT AND NO FURTHER EVENTS HAVE BEEN REPORTED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE INSTRUCTIONS FOR USE LISTS BLEEDING AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT WAS AGITATED WITH HIGH RESPIRATORY DRIVE, REINTUBATED, CT REVEALED SUBARACHNOID HEMORRHAGE AND ANTICOAGULATION WAS STOPPED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT EXPERIENCED A SMALL SUBARACHNOID BLEED FOR WHICH THE ANTICOAGULATION WAS STOPPED. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED HOME AND REMAINS ONGOING ON VAD SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417580 HEARTMATE II LEFT VENTRICULAR ASSIST DRIVE LEFT VENTRICULAR ASSIST DRIVE DSQ THORATEC CORP. 106015 139655

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention