BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2963447 · Received February 13, 2013

    Report

    Report Number
    2916596-2013-00184
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFORMATION RECEIVED, THE EXPLANTED DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MANUFACTURER RECEIVED A REPORT THROUGH DEVICE TRACKING STATING THAT THE PATIENT HAD RECEIVED A PUMP DUE TO A FAILED EXPLANT. ACCORDING TO THE ADDITIONAL INFORMATION PROVIDED, THE HOSPITAL HAD TRIED TO EXPLANT THE DEVICE FOR RECOVERY BUT FOR THE PATIENT EXPERIENCED HEART FAILURE AND NEEDED ANOTHER LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63098 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 93545

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention