BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2497263 · Received March 12, 2012

    Report

    Report Number
    2916596-2012-00209
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 13, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    2916596-2/24/12-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (2916596-2/24/12-001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFORMATION 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE HOSPITAL REPORTED THAT DURING CHEST CLOSURE, THE SURGEON NOTED THAT THE OUTFLOW GRAFT BEND RELIEF MOVED AS STERNAL WIRES WERE BEING TIGHTENED. THE BEND RELIEF APPEARED TO DISCONNECT PARTIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 110861

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR