BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3142976 · Received May 30, 2013

    Report

    Report Number
    2916596-2013-00680
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    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 THE 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 VENTILATOR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE TRANSPLANT COORDINATOR THAT THE PT RECEIVED A TRANSPLANT. ADDITIONAL INFO PROVIDED STATED THAT THE PT WAS HAVING INFECTION ISSUES ORIGINATING FROM A PERCUTANEOUS LEAD INFECTION AND HAD ANTIBIOTIC (ABX) TREATMENTS AND WOUND VACS. THE TRANSPLANT WAS NOT URGENT, BUT BECAME MORE OF AN OPTION AS THE INFECTION BECAME MORE OF A PROBLEM. THE PT ALSO RECENTLY EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA) AND WAS AT RISK FOR PUMP THROMBOEMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238400 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 108896

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR