BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2431065 · Received January 26, 2012

    Report

    Report Number
    2916596-2012-00039
    Event Type
    Injury
    Date Received
    January 26, 2012
    Date of Event
    July 5, 2011
    Report Date
    December 29, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS TRANSPLANTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE HOSP REPORTED THAT THE PT WAS PREVIOUSLY TRANSPLANTED SUCCESSFULLY FOLLOWING A HISTORY OF POWER FLUCTUATIONS AND REPORTED THROMBUS. UPON FURTHER INVESTIGATION ON (B)(6) 2011, THE OUTFLOW GRAFT BEND RELIEF WAS FOUND TO BE UNATTACHED VIA X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 103749

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention