BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3082174 · Received April 25, 2013

    Report

    Report Number
    2916596-2013-00495
    Event Type
    Death
    Date Received
    April 25, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WAS ADVISED THAT THE LVAD PUMP WAS NOT EXPLANTED AND WILL NOT BE RETURNING FOR EVAL. NO FURTHER INFORMATION 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPIRED. THE CAUSE OF DEATH IS UNK AT THIS TIME. THE PT WAS FOUND DEAD AT HOME. ADDITIONAL INFORMATION OBTAINED STATED THAT THE CARDIOLOGIST SUSPECTS THAT THE PT HAD A VENTRICULAR FIBRILLATION (V-FIB) ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180451 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 96981

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death