BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3093812 · Received April 30, 2013

    Report

    Report Number
    2916596-2013-00516
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    February 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT HAD ISSUES WITH DRIVELINE INFECTION SINCE (B)(6) 2013. THE PATIENT¿S INFECTION WAS TREATED AFTER THE PATIENT STATED THAT A BINDER WAS NOT WORN FOR ONE DAY. ON (B)(6) 2013, THE VAD COORDINATOR INDICATED THAT THE PATIENT WAS CONTINUING ON ANTIBIOTICS. ON PATIENT FOLLOW-UP, THE PATIENT HAS BEEN MOVED TO 1A STATUS FOR TRANSPLANT DUE TO THE DRIVELINE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186708 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 118144

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other