BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3004050 · Received March 12, 2013

    Report

    Report Number
    2916596-2013-00256
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    December 13, 2012
    Report Date
    February 11, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PUMP WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. THE USER FACILITY REPORT # 2201160000-2013-9029, WAS RECEIVED FROM THE (B)(4). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT AFTER 4 MONTHS OF SUPPORT, THE PATIENT WAS ADMITTED DUE TO HIGH LACTATE DEHYDROGENASE (LDH) AND POWER ELEVATIONS. PER THE VAD COORDINATOR, THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS NEVER SUBTHERAPEUTIC. THE HOSPITAL SUBSEQUENTLY MADE A DECISION TO EXPLANT THE LVAD AND THE PATIENT WAS IMPLANTED WITH A BIVENTRICULAR DEVICE (BIVAD) FROM ANOTHER MANUFACTURER. THE PATIENT REPORTEDLY REQUIRED A RVAD FOR RIGHT VENTRICLE SUPPORT DUE TO VENTRICULAR TACHYCARDIA (VT), NOT RIGHT VENTRICLE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103964 HEARTMATE II LVAS VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 117490

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention