BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2941600 · Received January 28, 2013

    Report

    Report Number
    2916596-2013-00097
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 7, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHED USER FACILITY REPORT WAS RECEIVED FROM THE (B)(4). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. AN (B)(6) REPORT WAS RECEIVED WHICH STATED: "SPLENIC INFARCTION - LIKELY FROM CLOT FROM LVAD/HEART." NO OTHER INFORMATION WAS PROVIDED WITH THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37809 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 116107

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention