BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2843447 · Received November 19, 2012

    Report

    Report Number
    2916596-2012-01116
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 24, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. 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 (LVAD). THE VAD COORDINATOR REPORTED THAT IT WAS RECENTLY NOTICED THAT THE PT WAS HAVING INCREASING PUMP POWER AND DROPPING PULSATILITY INDEX (PI) LEVELS. DURING A CLINIC VISIT, THE PT'S BLOOD WORK SHOWED ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS. AN ECHOCARDIOGRAM (TEE) PERFORMED BY THE HOSPITAL REVEALED A DILATED LEFT VENTRICLE (LV) WITH DIMINISHED FLOW THROUGH THE PUMP. THE PT WAS SUBSEQUENTLY LISTED AS UNOS STATUS 1A DUE TO DEVICE FAILURE/SUSPECTED THROMBUS. A HEART WAS RECEIVED FROM A DONOR AND THE PT WAS SUCCESSFULLY TRANSPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 112483

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention