BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2912979 · Received January 9, 2013

    Report

    Report Number
    2916596-2013-00004
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 6, 2012
    Report Date
    December 13, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. 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. THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS TRANSPLANTED ON (B)(6) 2012. THE PUMP WAS SENT BACK DUE TO THE PATIENT EXPERIENCING HEMOLYSIS DURING THE MONTHS PRIOR TO THE TRANSPLANT. THE HOSPITAL SUSPECTED PUMP THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12586 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 107485

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention