BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4202974 · Received October 23, 2014

    Report

    Report Number
    2916596-2014-01931
    Event Type
    Death
    Date Received
    October 23, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFO PROVIDED AND DUE TO THE PUMP NOT BEING AVAILABLE FOR EVAL, A SPECIFIC CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFO IS AVAILABLE. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. A REPORT WAS RECEIVED THROUGH THE DEVICE TRACKING SYSTEM WHICH INDICATED THAT THE PT EXPIRED WITH THE CAUSE OF THE EXPIRATION BEING NOTED AS "MCP." THE INFO RECEIVED FROM THE HOSP STAFF INDICATED THAT THE IMMEDIATE CAUSE OF DEATH WAS RESPIRATORY ARREST. THE DEATH WAS DUE TO CONSEQUENCE OF LARGE INTRAPARENCHYMAL HEMATOMA. IT WAS REPORTED THAT THE PT WAS ADMITTED ON (B)(6) 2013 AND THE PT EXPIRED ON (B)(6) 2014. ACCORDING TO THE HOSP, A PUMP RETURN IS NOT EXPECTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676355 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 125652

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death