BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2944977 · Received February 1, 2013

    Report

    Report Number
    2916596-2013-00118
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON GOING WITH THE IMPLANTED DEVICE. 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 SURGEON REPORTED THAT THE PATIENT HAD A DRIVELINE INFECTION NEAR THE EXIT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44845 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 108210

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention