BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3812794 · Received May 6, 2014

    Report

    Report Number
    2916596-2014-00740
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    February 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. 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

    BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, A ROOT CAUSE FOR THE REPORT OF AORTIC INSUFFICIENCY AND VENTRICULAR TACHYCARDIA COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS MOVED UP ON THE TRANSPLANT LIST DUE TO AORTIC INSUFFICIENCY (AI). THE HOSPITAL STAFF IS CLOSELY MONITORING THE PATIENT WITH ECHO'S.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT WAS READMITTED FOR VENTRICULAR TACHYCARDIA AND THE PUMP WAS FUNCTIONING OK. THE PATIENT WAS ULTIMATELY TRANSPLANTED ON (B)(6) 2014, HOWEVER THE PUMP WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION/ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271661 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 1355 74332

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention