BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2885069 · Received December 19, 2012

    Report

    Report Number
    2916596-2012-01242
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 27, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE ADDITIONAL INFO FROM THE HOSPITAL REGARDING THE EVENT AND THE PRODUCT DISPOSITION. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MANUFACTURER RECEIVED A REPORT THROUGH DEVICE TRACKING INDICATING THAT THE PT HAD RECEIVED A PUMP DUE TO A DRIVELINE INFECTION. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 80945

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention