BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3004011 · Received March 12, 2013

    Report

    Report Number
    2916596-2013-00263
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    July 29, 2011
    Report Date
    February 11, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED. THE USER FACILITY REPORT (B)(4) WAS RECEIVED FROM THE INTERMACS REGISTRY.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MANUFACTURER RECEIVED USER FACILITY REPORT (B)(4) FROM THE INTERMACS REGISTRY INDICATED THAT THE PATIENT RECEIVED A DEBRIDEMENT OF LVAD PERCUTANEOUS LEAD INFECTION, INCLUDING SKIN, SUBCUTANEOUS TISSUE AND MUSCLE/REMOVAL OF ANTIBIOTIC BEADS/COVERAGE OF LVAD PERCUTANEOUS LEAD WITH FASCIOCUTANEOUS FLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103849 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 94251

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention