BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3030315 · Received March 28, 2013

    Report

    Report Number
    2916596-2013-00350
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE TRANSPLANT COORDINATOR THAT THE PT WAS PRESENTED WITH LOWER STERNAL INFECTION AND IT CURRENTLY BEING TREATED WITH ANTIBIOTICS. ADDITIONAL INFO RECEIVED CONFIRMED THAT THE LVAD WAS EXCHANGED WITH ANOTHER LVAD ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128340 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 119462

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention