BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2890517 · Received December 26, 2012

    Report

    Report Number
    2916596-2012-01259
    Event Type
    Death
    Date Received
    December 26, 2012
    Date of Event
    October 12, 2012
    Report Date
    December 4, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING ADD'L INFO AND ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED. THE ATTACHED USER FACILITY REPORT WAS RECEIVED FROM THE (B)(6) REGISTRY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR RECEIVED A USER FACILITY REPORT RECEIVED FROM THE (B)(6) REGISTRY WHICH STATED: "DRIVELINE DAMAGED WITH SUSPECTED WIRE FRACTURE. NOT A CANDIDATE FOR REPLACEMENT". THE OUTCOME OF "DEATH" WAS REPORTED ON THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 92432

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death