BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3011044 · Received March 11, 2013

    Report

    Report Number
    2916596-2013-00270
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 11, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORT #(B)(4) WAS RECEIVED FROM THE (B)(4) REGISTRY. NOTE: THE EVENT DATE WAS REPORTED ON THIS USER FACILITY REPORT AS (B)(4) 2013; HOWEVER, THE HOSPITAL REPORTED TO THE MFR THAT (B)(4) WAS EXPLANTED ON (B)(6) 2013. THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE BIO-MED REPORTED THAT THE PT'S PUMP WAS EXPLANTED DUE TO SUSPECTED THROMBUS. THE PUMP IS BEING RETURNED FOR EVAL. AN (B)(4) REGISTRY REPORT WAS SUBMITTED TO THE MFR WITH ADDITIONAL INFORMATION INDICATING THAT THE PT WAS EXPLANTED DUE TO MULTIPLE SPEED FLUCTUATIONS AND POSSIBLE PUMP THROMBUS. HEPARIN WAS ADMINISTERED BY INTRAVENOUS (IV) AND INTEGRILIN WAS STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102583 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 120723

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention