BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2484722 · Received March 6, 2012

    Report

    Report Number
    2916596-2012-00204
    Event Type
    Injury
    Date Received
    March 6, 2012
    Date of Event
    November 1, 2011
    Report Date
    February 6, 2012
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD WAS SUCCESSFULLY EXCHANGED AND THE PT REMAINS ONGOING WITHOUT ANY FURTHER ISSUE REPORTED. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT HAD A COMPLETED POST-OPERATIVE COURSE DUE TO EMBOLI AND AN INFARCTED BOWEL THAT RESULTED IN AN ILEOSTOMY. POST-IMPLANT OF THE LVAD AND PRIOR TO THE INITIAL DISCHARGE FROM THE HOSPITAL, THE PT HAD REPORTEDLY PRESENTED WITH HIGH PUMP POWER AND A DECISION WAS MADE BY THE HOSPITAL TO EXCHANGE THE LVAD DUE TO SUSPECTED THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP 104911 107479

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention