BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE LVAS

    MDR report key: 3170008 · Received June 7, 2013

    Report

    Report Number
    2916596-2013-00704
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORT # (B)(4) WAS RECEIVED FROM THE (B)(4) REGISTRY. NOTE: THE EVENT DATE WAS REPORTED ON THIS USER FACILITY REPORT AS (B)(6) 2013; HOWEVER, THE HOSPITAL REPORTED TO THE MANUFACTURER THAT (B)(4) WAS REPLACED ON (B)(6) 2013. THE EXPLANTED DEVICE 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 DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PERFUSIONIST REPORTED THAT THE PT HAD A PUMP EXCHANGE DUE TO SUSPECTED THROMBOSIS. THE MANUFACTURER LATER RECEIVED ADDITIONAL INFO FROM (B)(4) REGISTRY INDICATING THAT THE PT HAD ELEVATED LACTATE DEHYDROGENASE (LDH) THAT DAY AND WORSENING HEMOGLOBIN AT 6.7. PLASMA HEMOGLOBIN 35 WITH PT SHOWING A DECLINE IN BOTH FUNCTIONAL STATUS AS WELL AS HIS FLUID STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253724 HEARTMATE LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 116756

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention