BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2922489 · Received January 10, 2013

    Report

    Report Number
    2916596-2013-00035
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    October 11, 2012
    Report Date
    December 14, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR REC'D THE ATTACHED USER FACILITY REPORT ((B)(4)) FROM THE (B)(6) REGISTRY. THE REPORT INDICATED THAT THE PT PRESENTED WITH DRAINAGE FROM HIS DRIVELINE AND HAD A MEDIASTINAL INFECTION. IT ALSO STATED THAT THE PT "HAD IRRIGATION, RESECTION OF DEEP FACIAL TISSUES AND PLACEMENT OF WOUND VACUUM ASSISTED CLOSURE (VAC)." THE PT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13257 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 110281

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention