BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2874389 · Received December 14, 2012

    Report

    Report Number
    2874389
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 16, 2012
    Report Date
    December 13, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT NOTED A SEPARATION IN HIS DRIVELINE AT THE POINT OF INSERTION TO THESYSTEM CONTROLLER. DENIES ALARMS, CHANGES IN VAD DATA OR NEW SYMPTOMS. THORATEC ENGINEER APPLIED "CLAMSHELL" REPAIR TO DRIVELINE WITHOUT ISSUE AT BWH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1