BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2973022 · Received February 21, 2013

    Report

    Report Number
    2973022
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    August 7, 2012
    Report Date
    February 21, 2013
    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

    PT NOTED A SMALL HOLE IN THE SILICONE COVERING OF HIS DRIVELINE NEAR THE SYSTEM CONTROLLER, NO WIRES WERE EXPOSED.PT CAME TO CLINIC AND RESCUE TAPE WAS APPLIED TO THE AREA. NO ALARMS WERE NOTED. NO FURTHER ISSUES TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77098 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1