BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 1971518 · Received January 21, 2011

    Report

    Report Number
    2916596-2011-00027
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 28, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT HAD BEEN HAVING TRANSIENT INCREASES IN PLASMA FREE HGB ALONG WITH SOME POWER SPIKES. IN ADDITION, THE PATIENT HAD HIGHLY EVIDENT HEMOLYSIS THAT WAS ASSOCIATED WITH POWER SPIKES. A DECISION WAS MADE TO EXCHANGE THE LVAD WITH ANOTHER LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 96716

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention