BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3950513 · Received July 11, 2014

    Report

    Report Number
    2916596-2014-01179
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING ON LVAD SUPPORT AND WILL CONTINUE TO BE MONITORED BY THE HOSPITAL FOR NEUROLOGICAL RECOVERY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING ON VAD SUPPORT; THEREFORE THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED SUBARACHNOID HEMORRHAGE COULD NOT BE CONCLUSIVELY DETERMINED. AS OF (B)(6) 2015, THE PATIENT WAS REPORTED TO BE DOING WELL AND THAT THE EVENT WAS NOT DEVICE RELATED. THE INSTRUCTIONS FOR USE LISTS BLEEDING AND STROKE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT 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). THE VAD COORDINATOR REPORTED THAT THE PATIENT SUFFERED SUBARACHNOID HEMORRHAGE AND WAS READMITTED TO THE HOSPITAL. THE HOSPITAL WILL CONTINUE TO MONITOR THE PATIENT FOR NEUROLOGICAL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407951 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 112482

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention