BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 4067719 · Received August 13, 2014

    Report

    Report Number
    2916596-2014-01287
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 15, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD WAS RETURNED TO THE MANUFACTURER FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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. THE HOSPITAL REPORTED THAT THE PT HAD AN EMERGENT OHT (HEART TRANSPLANT) DUE TO HIGH LDH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482850 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 138291

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention